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<h3>Job Description</h3>
Job Description
Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.
Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.
Summary: 
The Instruments Engineering team is a highly energetic and actively growing team that is responsible for developing and ultimately driving Calyxo's instruments and accessories from concept to launch and beyond We are looking for a Senior R&amp;D Sustaining Engineer to drive design solutions and support process enhancements for commercialized products, working closely alongside the systems, vision and sensors, and software R&amp;D teams, to catalyze the advancement of an innovative, single-use kidney stone treatment devices. You will be immersed in a highly collaborative and multidisciplinary team, teaming up with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to integrate and implement these solutions into our commercialized product(s).
In This Role, You Will:
<ul>
<li>Lead and inform the design, development and qualification strategy for design-related product enhancements and line extensions in response to internal and/or external feedback.</li>
<li>Lead design-related root cause analysis efforts, and drive corrective and preventive actions.</li>
<li>Serve as an R&amp;D SME for projects lead by cross-functions, and partner with cross-functional teams to gain alignment on qualification strategies.</li>
<li>Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development.</li>
<li>Collaborate with the Post-Market Surveillance team to support effective root cause analysis of device issues returning from the field.</li>
<li>Ensure design and development pathways maintain adherence to the design control process, working with cross-functional partners to enable manufacturability, reliability, and scalability.</li>
<li>Use SolidWorks to create well-defined models, assemblies, and engineering drawings.</li>
<li>Support the generation of new or revised product requirements and engineering specifications.</li>
<li>Create and execute protocols, and author associated reports and risk documentation, developing and validating new test methods as needed.</li>
<li>Effectively communicate project progress, results, and risks to relevant stakeholders.</li>
<li>Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing as needed, ensuring alignment with project goals and timelines.</li>
</ul>
Who You Will Report To:
<ul>
<li>See Organizational Chart</li>
</ul>
Requirements:
<ul>
<li>Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field</li>
<li>5+ years of medical device experience (4+ with an advanced degree).</li>
<li>Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820.</li>
<li>Ability to apply DFX principles to create designs that can scale.</li>
<li>Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance stack analysis, and GD&amp;T.</li>
<li>Track record of taking design concepts from prototyping stage through to design maturation.</li>
<li>Proven design capabilities in two or more of the following key areas: injection molding, electro-mechanical sub-systems, catheter construction, endoscope construction, fluidics.</li>
<li>Experience creating and running simulations (CFD, FEA) to inform product development.</li>
<li>Solid experience conducting structured design of experiments (DOEs) and using statistical methods to analyze data.</li>
<li>Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams.</li>
<li>Strong problem-solving and analytical skills, with a hands-on approach to product development and testing.</li>
<li>Compliance with relevant county, state, and Federal rules regarding vaccinations.</li>
</ul>
What We Offer:
At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 
We also offer an attractive compensation package, which includes:
<ul>
<li>A competitive base salary and variable incentive plan</li>
<li>Stock options – ownership and a stake in growing a mission-driven company</li>
<li>Employee benefits package that includes 401(k), healthcare insurance and paid vacation</li>
</ul>
Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth. Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics
Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. 
Disclaimer:
At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:
<ul>
<li>Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.</li>
<li>Verification of Identity: We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.</li>
<li>Beware of Scams: Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of <a href="mailto:firstname.lastname@calyxoinc.com" target="_blank">firstname.lastname@calyxoinc.com</a>. If you receive a request for information from any other domain, please contact us directly at <a href="mailto:info@calyxoinc.comto" target="_blank">info@calyxoinc.comto</a> verify the legitimacy of the communication.</li>
</ul>
We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.

Senior R&D Sustaining Engineer, Instruments - Pleasanton, CA

<h3>Job Description</h3>
Job Title: Quality Engineer – Medical Devices
Location: Chicago, IL (Onsite)
Duration: 12-Month Contract (with potential for extension)
 
Key Responsibilities:
<ul>
<li>Support Quality System maintenance in accordance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory standards.</li>
<li>Lead and support Non-Conformance (NC) and Corrective and Preventive Action (CAPA) investigations; perform root cause analysis using tools like 5 Whys, Fishbone, FMEA.</li>
<li>Participate in validation activities (IQ/OQ/PQ) for equipment, processes, and software.</li>
<li>Review and approve Engineering Change Orders (ECOs), Deviations, and Document Changes.</li>
<li>Provide quality input during Design Control and Risk Management processes.</li>
<li>Perform internal audits and support regulatory inspections (FDA, ISO, MDSAP).</li>
<li>Collaborate with manufacturing, R&amp;D, and supply chain teams to ensure product quality.</li>
<li>Support supplier quality activities and perform incoming inspection audits when required.</li>
<li>Create and revise Standard Operating Procedures (SOPs) and Work Instructions (WIs).</li>
<li>Monitor product performance trends and support continuous improvement projects.</li>
</ul>
 
Qualifications:
<ul>
<li>Bachelor’s degree in Engineering, Life Sciences, or a related field (Biomedical/Mechanical preferred).</li>
<li>Minimum 3-5 years of experience as a Quality Engineer in medical device or regulated industries.</li>
<li>Solid understanding of FDA regulations, ISO 13485, ISO 14971, and risk-based approaches.</li>
<li>Experience with CAPA systems, Change Control, Complaint Handling, and Root Cause Investigations.</li>
<li>Familiarity with tools such as TrackWise, MasterControl, Greenlight Guru, or similar QMS platforms.</li>
<li>Proficient in MS Office, especially Excel and Word; knowledge of Minitab is a plus.</li>
<li>Certifications like CQE, Six Sigma, or Lean are desirable.</li>
</ul>

Quality Engineer - Medical Devices

<h3>Job Description</h3>
Job Description
Riverpoint Medical in Portland, Oregon is looking to hire a Process Engineer III. At Riverpoint you will be part of the process that brings great technology to Medical, Dental and Veterinary markets. We specialize in the design and manufacturing of premium medical devices. Our ingenuity can be found in our suture technologies, sports medicine fibers and anchors, surgical lighting, and special needle technologies. Riverpoint Process Engineer III is responsible for driving proactive improvements to internal systems, processes and new equipment validations. The PE will collaborate with Operations, New Product Development, Quality, and Regulatory teams to produce robust solutions towards process improvement.
Duties &amp; Responsibilities:
<ul>
<li>Plan, conduct, and manage projects in support of the company's strategic plan through implementation of the ECO processes.</li>
<li>Complete engineering projects by organizing and controlling project elements and coordinating activities (internal and external) of the project team.</li>
<li>Understand customer requirements and effectively implement them into the Riverpoint QMS system.</li>
<li>Determines project schedule by studying project plan and specifications, calculating time requirements, and sequencing project elements.</li>
<li>Assist in the management of compliance, quality control, and quality assurance standards and specifications.</li>
<li>Engage outside contracting services in support of project needs, i.e. analytical laboratories, consultants, material suppliers and equipment suppliers. </li>
<li>Build effective relationships with these resources to meet delivery and budgetary goals.</li>
<li>Ensure completion of new product additions across all build documentation, labeling, and ERP functions for effective transfer to production.</li>
<li>Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.</li>
</ul>
Education and Qualifications:
<ul>
<li>Bachelor’s degree or equivalent work experience in Mechanical, Materials Science, Chemical, Electrical or Biomedical engineering, graduate degree preferred.</li>
<li>Previous experience working with medical devices, product development, reprocessing and/or manufacturing (4-10 years).</li>
<li>Regulatory Experience working in an FDA regulated environment, or similar (4-10 years).</li>
<li>Experience executing equipment and process validation activities such as IQ/OQ/PQ</li>
<li>Exposure to the FDA 510(k) process or other regulatory submissions</li>
<li>Prior experience in a LEAN Manufacturing/Production environment, GMP and/or New Product Development</li>
<li>Prior experience in medical device sterilization, sealing and/or packaging preferred.</li>
</ul>
We offer great benefits: Medical, Dental and Vision, Life and Accidental Death Insurance; 401(k) with company match and immediate vesting, Paid Time Off and 9 company paid holidays.
Riverpoint Medical is committed to a diverse and inclusive workplace. Riverpoint Medical is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

Process Engineer III

<h3>Job Description</h3>
Job Description
Responsibilities:
<ul>
<li>Perform systems engineering activities and assist in the preparation of a work product in Technical Process Areas associated with the ISO/IEC 15288</li>
<li>Develop and deliver a work product in any of the ISO/IEC 15288 Process Areas</li>
<li>Perform analysis of technical alternatives for a project and make preliminary recommendations</li>
<li>Assist in performing systems engineering activities in the ISO/IEC 15288 Agreement or Enterprise Process Areas</li>
<li>Perform systems engineering activities and assist in the preparation of multiple work products in Project and/or Technical Process Areas associated with any of the ISO/IEC 15288 processes</li>
<li>Perform systems engineering activities and develop and deliver work products in each of the ISO/IEC 15288 Project and Technical Process Areas</li>
<li>Independently analyze, and recommend alternatives for elements of projects technical design</li>
<li>Perform systems engineering activities and develop and deliver work products of either the ISO/IEC 15288 Agreement or Enterprise Process Areas</li>
</ul>
Required Skills:
<ul>
<li>Must be a U.S. Citizen</li>
</ul>
<ul>
<li>TS/SCI with polygraph required</li>
<li>A Bachelors degree in a Qualified Engineering Field (Aeronautics, Biomedical, Chemical, Civil, Computer, Electrical, Environmental, Mechanical, Nuclear, Software, Systems, and Engineering Management) or a related discipline (Chemistry, Computer Science, Information Systems, Mathematics, and Physics) from an accredited college or university plus six (6) years of systems engineering experience OR A High School Diploma or GED plus ten (10) years of general system engineering experience (any Process Area). OR A Masters degree in a Qualified Engineering Field (Aeronautics, Biomedical, Chemical, Civil, Computer, Electrical, Environmental, Mechanical, Nuclear, Software, Systems, and Engineering Management) or a related discipline (Chemistry, Computer Science, Information Systems, Mathematics, and Physics) from an accredited college or university plus four (4) years of systems engineering experience OR A PhD in a Qualified Engineering Field (Aeronautics, Biomedical, Chemical, Civil, Computer, Electrical, Environmental, Mechanical, Nuclear, Software, Systems, and Engineering Management) or a related discipline (Chemistry, Computer Science, Information Systems, Mathematics, and Physics) from an accredited college or university plus four (4) years of systems engineering experience</li>
</ul>
Compensation Range: $121,361.04 - $241,142.06
_____________________________________________________________________________________________________
Compensation ranges encompass a total compensation package and are a general guideline only and not intended as a guaranteed and/or implied final compensation or salary for this job opening. Determination of official compensation or salary relies on several different factors including, but not limited to: level of position, complexity of job responsibilities, geographic location, candidate’s scope of relevant work experience, educational background, certifications, contract-specific affordability, organizational requirements and alignment with local market data. 
Our compensation includes other indirect financial components designed to support employees’ total well-being, which should be considered when evaluating our competitive benefits package. These monetary benefits include medical insurance, life insurance, disability, paid time off, maternity/paternity leave, 401(k) company match, training/education reimbursements and other work/life programs.
_____________________________________________________________________________________________________
IntelliGenesis is committed to providing equal opportunity to all employees and applicants for employment. The Company is an Equal Opportunity Employer (EOE), and as such, does not tolerate discrimination, retaliation, or harassment of its employees or applicants based upon race, color, religion, gender, sexual orientation, national origin, age, genetic information, disability, or any other protected characteristic under local, state, or federal law in any employment practice. Such employment practices include, but are not limited to: hiring, promotion, demotion, transfer, recruitment, or recruitment advertising, selection, disciplinary action layoff, termination, rates of pay, or other forms of compensation and selection of training. 
IntelliGenesis is committed to the fair and equal employment of individuals with disabilities. It is the Company’s policy to reasonably accommodate qualified individuals with disabilities unless the accommodation would impose an undue hardship on the organization. In accordance with the Americans with Disabilities Act (ADA) as amended, reasonable accommodations will be provided to qualified individuals with disabilities, when such accommodations are necessary, to enable them to perform the essential functions of their jobs or to enjoy the equal benefits and privileges of employment. This policy applies to all applicants for employment and all employees.
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System Engineer Level 3

<h3>Job Description</h3>
Job DescriptionDescription:
Job Brief
We are seeking an experienced Sr. Design Engineer to provide leadership support to our Spinal Hardware Products team within the R&amp;D department. The Senior Design Engineer will be responsible for the design, development, verification and validation of new and existing products for our spinal hardware portfolio. This role requires a strong technical background in mechanical engineering, desire to grow in leadership and the ability to collaborate effectively across teams. The Sr. Design Engineer will play a pivotal role in driving innovation, ensuring product quality, and meeting regulatory requirements in the spinal medical device sector.
 
Responsibilities
<ul>
<li>Primary leader of assigned product development and sustaining projects.</li>
<li>Collaborate with cross-functional teams including R&amp;D, Quality Assurance, Manufacturing, and Regulatory Affairs to achieve project goals and timelines.</li>
<li>Execute on the design, development, verification, and validation of new products, ensuring alignment with market needs and regulatory requirements.</li>
<li>Execute detailed mechanical component and assembly CAD models.</li>
<li>Generate detailed product drawings and component specifications.</li>
<li>Manage design transfer activities from R&amp;D to manufacturing, optimizing processes and ensuring scalability.</li>
<li>Manage and prioritize sustaining engineering efforts for existing products, addressing design improvements, and manufacturing optimizations.</li>
<li>Implement corrective actions and continuous improvement initiatives based on post-market feedback and quality data.</li>
<li>Ensure compliance with FDA regulations (e.g., 21 CFR Part 820) for medical devices.</li>
<li>Collaborate with Regulatory Affairs to support regulatory submissions.</li>
<li>Evaluate and recommend technologies, tools, and resources necessary for product development and sustaining activities.</li>
</ul>
Requirements:
Qualifications
<ul>
<li>Minimum B.S. degree in Mechanical Engineering, Biomedical Engineering, or related field.</li>
<li>Minimum 5 years of experience in engineering roles within the medical device industry.</li>
<li>Strong background in medical device product development, including design, testing, and manufacturing processes.</li>
<li>Knowledge of materials selection, manufacturing processes (e.g., machining, casting), and product lifecycle management.</li>
<li>Experience in analytical processes (e.g., FEA, numerical modeling, Risk Analysis).</li>
<li>Experience with contract manufacturer development and working relationships.</li>
<li>Experience with implantable medical devices or surgical instrumentation.</li>
<li>Familiarity with design for manufacturability (DFM) and design for assembly (DFA) principles.</li>
<li>Excellent organizational and communication skills.</li>
<li>Ability to prioritize tasks and manage multiple projects effectively.</li>
<li>Hands-on, driven work ethic.</li>
</ul>
Physical Requirements
This is largely a sedentary role; prolonged periods sitting at a desk and working on a computer. This would require the ability to lift files, open filing cabinets and bend or stand as necessary.
 
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Sr. Design Engineer

<h3>Job Description</h3>
Job DescriptionSalary: 
 
Purpose
The Project Engineer will support existing and new products with project management and development. This will include product management, prototyping, testing, and marketing associated with products.
 
Responsibilities
<ul>
<li>Manage and execute product development projects from ideation to market launch</li>
<li>Lead project management activities on assigned projects including schedule, budget, work products and deliverables</li>
<li>Execute projects following design control practices and developing the necessary project inputs and outputs required for each development phase</li>
<li>Organize appropriate methods of communication between project stakeholders</li>
<li>Collect, organize, and communicate customer and market feedback to identify critical product characteristics</li>
<li>Develop scalable and repeatable manufacturing processes for new products in collaboration with the Quality Assurance (QA) and Operations departments</li>
<li>Author and revise standard operating procedures (SOP) according to FDA, AATB, and other regulations if applicable</li>
<li>Review, analyze, and characterize critical financial characteristics of products including COGS</li>
<li>Conduct group trainings for new processes and complete technology transfer of new products</li>
<li>Perform processing of human tissue as part of the development of new processes</li>
<li>Design and execute scientific experiments for product development projects. Complete data collection, evaluation, and interpretation of results to generate statistically significant data to support project decisions and/or product launch</li>
<li>Specify, order, evaluate, and onboard new proprietary equipment in support of products</li>
<li>Execute and plan new company initiatives including equipment onboarding, supply chain management, distribution capability, and product support</li>
<li>Design and develop custom manufacturing equipment if applicable</li>
<li>Support and expand existing product lines by responding to business development needs, collecting, and organizing product feedback, and improving and supporting products</li>
<li>Support the development and implementation of sales material for products and work with Quality Assurance to ensure all claims are appropriate for market and regulatory position</li>
<li>Conduct literature reviews to support new and existing products</li>
<li>Assist with investigation of product quality events and appropriate preventative/corrective actions</li>
<li>Support regulatory and reimbursement submissions for products</li>
<li>Develop and execute validation protocols in accordance with regulatory requirements. Review validation data and draft validation reports</li>
<li>Identify and develop a working knowledge of ASTM, AAMI, ISO, and other necessary validation or testing guidance's required for assigned product development projects</li>
<li>Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures</li>
<li>Perform other duties as assigned</li>
<li>Maintain acceptable attendance and punctuality for scheduled work hours and meetings</li>
<li>Ensure completion of assigned tasks and responsibilities within defined timeframes</li>
<li>Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice, to support business/operational needs when necessary</li>
<li>Complete required hours on assigned duties works shift to complete assigned responsibilities and duties</li>
</ul>
Skills
<ul>
<li>Project Management experience</li>
<li>Ability to present complex ideas</li>
<li>Technical writing ability</li>
<li>Knowledge of manufacturing environment and validation procedures</li>
<li>Strong analytical and creative thinking skills</li>
<li>Ability to work in a fast-paced environment</li>
<li>Ability to work independently and in a team environment</li>
<li>Proficient in Microsoft Office</li>
<li>Experience working with vendors and suppliers</li>
</ul>
Qualifications/Requirements
<ul>
<li>Bachelor's degree in biomedical or mechanical engineering or related field required</li>
<li>3 years of experience in project management required</li>
<li>Experience with Mechanical Design</li>
<li>Experience with CAD Software</li>
<li>Education in Engineering, or Biological Science or related field preferred</li>
<li>Product Development and exposure to medical products preferred</li>
<li>Experience with allografts and/or medical devices preferred</li>
<li>Clearance of favorable background investigation required</li>
</ul>

Project Engineer - Tissue

<h3>Job Description</h3>
Job DescriptionDescriptionProvide design, engineering, and analysis support to other engineers and designers in the development and maintenance of orthopedic implants and instruments. Key Responsibilities
<ul>
<li>Provide design, engineering, and analysis support to other engineers and designers in the development and maintenance of orthopedic implants and instruments.</li>
<li>Apply sound engineering problem-solving techniques to product development and maintenance tasks including design, analysis, material selection, inspection requirements and manufacturing process requirements.</li>
<li>Prepare and submit written and oral communications that describe product design concepts, attributes and performance and project status. Areas of involvement include regulatory submissions, design history files, device evaluation and testing, manufacturing or supplier support, quality control, packaging, operating room support, device complaint evaluation, patent disclosures and instrument refurbishment.</li>
<li>Define and execute product testing and validation protocols.</li>
<li>Establish appropriate project plan (i.e. define tasks, dependencies, schedule and resource requirements).</li>
<li>Complete and approve all Design History File documentation for assigned projects as required.</li>
<li>Lead a cross-functional project team (including both internal and external team members such as orthopedic surgeons) of one or several minor development projects. A minor project involves the modification, adaptation or extension of an existing product or product line.</li>
<li>Study and recommend improvements to existing products and processes. This entails staying “up to date” on emerging material and medical product technologies. This may be accomplished by attending seminars, classes and industry meetings. Contribute to the timely and accurate completion of the projects and tasks assigned to his/her team.</li>
<li>Know and apply the Quality System and any appropriate Federal and International standards.</li>
<li>Assist and support other employees, teams, and sales personnel as necessary.&nbsp;</li>
</ul>
 Skills Knowledge and ExpertiseEducation:
<ul>
<li>Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering or equivalent from an accredited institution required.</li>
</ul>
&nbsp;Experience:
<ul>
<li>Must have a basic understanding of theoretical technical principles in the following areas: mechanical drafting, geometrical dimensioning and tolerancing, computer aided design, engineering statics and dynamics, mechanics of materials, mechanical engineering design, materials, and technical writing.&nbsp;</li>
</ul>
Functional/Technical Knowledge, Skills and Abilities Required:
<ul>
<li>Must have excellent communication (verbal &amp; written) and organizational skills.</li>
<li>Must have excellent interpersonal skills and must be able to work effectively in a team environment.</li>
<li>Must be creative and have the ability to independently apply theoretical technical principles to product design.</li>
<li>Must have the ability to apply parametric solid modeling and drafting conventions to design projects.</li>
<li>Must have knowledge of various software packages including Microsoft Office applications and CAD applications.</li>
<li>To fully meet team responsibilities, the individual will develop additional knowledge and skills in anatomy and physiology, especially as related to the musculo-skeletal system, fundamentals of orthopedic surgery (major joints), mechanical test methods and procedures, quality and inspection methods, manufacturing processes and methods, FDA/ISO requirements, project management, orthopedic implants and the materials used in orthopedic implants and instruments.&nbsp;</li>
<li>Travel 5-10%&nbsp;</li>
</ul>

Product Design Engineer

<h3>Job Description</h3>
Job DescriptionJoin our dynamic team at DEKA and be at the forefront of driving quality excellence! As our Junior Quality Engineer, you'll be a key player in our collaborative environment, working hand-in-hand with cross-functional teams to ensure the highest standards of quality. Quality Engineering is a high-visibility role with a significant, direct impact on the success of the project. As a key contributor to our team, the following skills are required:
<ul>
<li>Aptitude for Learning Technical Information: Ability to comprehend and apply technical concepts effectively. Strong engineering foundation and technical skills.</li>
<li>Project Coordination/Management: Skilled in planning, executing, and managing projects with varying timelines.</li>
<li>Problem Solving: Embrace challenges and find creative solutions.</li>
<li>Collaboration: Effectively collaborate with various teams and departments, sharing ideas, taking initiative and proactively contribute to achieve common objectives. Work to maintain a positive attitude, fostering a supportive and productive work environment.</li>
<li>Attention to Detail: Display exceptional accuracy and precision in all tasks.</li>
<li>Effective Communication: Ability to articulate problems and solutions with clarity and precision to a diverse, cross-functional team with varying levels of technical aptitude</li>
<li>Self-Motivated: Able to self-prioritize and work independently.</li>
<li>Technical Writing: Proficient in conveying complex technical information clearly and concisely to as variety of audiences.</li>
<li>Excellent at utilizing or the ability to quickly learn applications, including Excel, Word, and Visio.</li>
</ul>
As a Jr. Quality Engineer, you will contribute in the following areas:
<ul>
<li>Ensure an overall level of product quality in line with DEKA’s standards</li>
<li>Support and participate in development of complex electromechanical devices</li>
<li>Assist in the development, implementation&nbsp;and approval of Device Master Records and Device History Records</li>
<li>Attain a comprehensive understanding of device design and core technologies, leveraging this knowledge to drive investigations and improvements in product design and process.</li>
<li>Participate in investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills</li>
<li>Participate in Risk Management activities in accordance with ISO 14971:2019 such as FMEAs and Risk Analysis</li>
<li>Use critical thinking and analysis to determine the best approach and provide guidance on QMS, FDA Part 820, and ISO 13485 compliance to design team members</li>
</ul>
<ul>
<li>Review and approve quality records to ensure accuracy, completeness, and compliance with regulatory requirements.</li>
</ul>
To be successful in this role as a Junior Quality Engineer, you will need the following skills:
<ul>
<li>BS or MS degree in Biomedical, Mechanical, Electrical, or&nbsp;a related engineering/ Science discipline</li>
<li>Ability to work as part of a multidisciplinary team</li>
<li>Excellent verbal and written communication skills, as well as&nbsp;attention to detail</li>
<li>Ability to understand and provide guidance on quality system procedures</li>
<li>Project coordination/ management skills</li>
<li>Technical Writing experience</li>
<li>Excel, Word, Visio skills</li>
</ul>
Nice skills to have:
<ul>
<li>Knowledge of FDA’s Quality System Regulation</li>
<li>Knowledge of ISO 13485 and related standards</li>
<li>Experience&nbsp;with Corrective and Preventive Action (CAPA)</li>
<li>1+ years’ experience in quality systems management, CAPA, quality assurance or a similar regulated environment</li>
</ul>
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research &amp; Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
 &nbsp;
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Junior Quality Engineer

<h3>Job Description</h3>
Job Description
CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.
The Support Systems Engineer plays a key role in implementing, configuring, and supporting multiple CareDx software platforms and HL7 interfaces. This role ensures system reliability, performance, and seamless customer experience within defined budgets and timelines.
Key Responsibilities:
<ul>
<li>
Technical Support &amp; Implementation
<ul>
<li>Deploy, configure, and support CareDx software, including transplant, medication, and patient management platforms.</li>
<li>Troubleshoot and resolve issues related to operating systems, databases (SQL, Oracle), and application interfaces.</li>
<li>Support and maintain HL7 interfaces, including custom filtering and performance monitoring.</li>
<li>Assist with remote connectivity setup and VPN configurations for customer sites.</li>
<li>Ensure compliance with SLAs while managing ticket queues and project timelines.</li>
</ul>
</li>
<li>
Customer Engagement &amp; Documentation
<ul>
<li>Advise customers on software and hardware requirements before deployment.</li>
<li>Provide ongoing support with a strong focus on customer service and follow-up.</li>
<li>Document processes, configurations, and troubleshooting steps for internal and external use.</li>
</ul>
</li>
<li>
Collaboration &amp; Continuous Improvement
<ul>
<li>Work independently to execute implementation plans and resolve technical issues.</li>
<li>Coordinate with cross-functional teams to optimize system performance.</li>
<li>Stay up to date with emerging technologies to improve deployment and support processes.</li>
</ul>
</li>
</ul>
Qualifications &amp; Experience:
<ul>
<li>Required:
<ul>
<li>Bachelor’s degree in MIS, Computer Science, or a related field (or equivalent experience).</li>
<li>2+ years of experience in system engineering, implementation, and automation.</li>
<li>Proficiency in writing complex SQL queries and managing Microsoft SQL Server &amp; Oracle databases.</li>
<li>Experience with SAP Crystal Reports and software interface troubleshooting.</li>
<li>Strong knowledge of Microsoft Windows Active Directory and VPN protocols (Cisco, Nortel, RDP, etc.).</li>
<li>Expectation is to be on call one week per month</li>
</ul>
</li>
<li>Preferred:
<ul>
<li>Experience in biomedical systems engineering.</li>
<li>Familiarity with IIS Web Services and website management.</li>
<li>Knowledge of coding languages such as Python, C++, or JavaScript.</li>
<li>Experience with data conversions and network administration.</li>
</ul>
</li>
</ul>
<ul>
<li>Success Metrics:
<ul>
<li>Provides timely and effective technical support with high customer satisfaction.</li>
<li>Ensures seamless software deployment with minimal disruptions.</li>
<li>Maintains accurate documentation and knowledge sharing.</li>
<li>Continuously enhances technical skills and industry knowledge.</li>
</ul>
</li>
</ul>
Remote: US only roles
The anticipated base salary range in the United States is $80,000 to $110,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives, and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states.
Additional Details:
Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.
Our competitive Total Rewards package includes:
<ul>
<li>Competitive base salary and incentive compensation</li>
<li>Health and welfare benefits including a gym reimbursement program</li>
<li>401(k) savings plan match</li>
<li>Employee Stock Purchase Plan</li>
<li>Pre-tax commuter benefits</li>
<li>And more!</li>
<li>
Please refer to our page to view detailed benefits at <a href="https://caredx.com/company/careers/" target="_blank">https://caredx.com/company/careers/</a>
</li>
</ul>
In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.
With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.
CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.
For HR administration purposes, the job title is Implementation &amp; Support Engineer I.
By proceeding with our application and submitting your information, you acknowledge that you have read our U.S. Personnel Privacy Notice and consent to receive email communication from CareDx.
******** We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us.
#LI-Remote

Support Systems Engineer

<h3>Job Description</h3>
Job DescriptionSage Product Development, Inc. Senior Product Development Engineer Reports To: Engineering Manager COMPANY OVERVIEW: Sage Product Development, Inc. provides fast, efficient and creative product development services to medical device companies. We are a focused team of experienced medical device engineers who know what it takes to develop successful products for startups, multinational companies, and everyone in between. We combine a high level of experience with a low overhead company structure. We solve client companies technical challenges and meet their product development needs in a timely, efficient and highly personalized manner. We offer the right candidate the opportunity to work in an entrepreneurial environment, enhance their product development engineering abilities, and build their network within the industry. GENERAL SUMMARY: 
<ul>
<li>Develop medical devices from concept through market introduction on a contract basis for client companies.</li>
<li>Meet or exceed customer expectations.</li>
</ul>
 ESSENTIAL JOB FUNCTIONS (all as required by client companies): 
<ul>
<li>Manage product development projects. Prepare project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs. Proactively communicate task assignments to responsible individuals, and ensure that tasks are completed within the planned time. Track projects to project plans. Proactively report project status to Sage personnel and to the projects client company.</li>
<li>Generate project timing and expense estimates and prepare project proposals for client companies.</li>
<li>Design and develop medical devices (disposable and reusable), catheters, equipment, implants, and/or packaging, from concept through market introduction. Ensure that designs meet performance specifications, regulatory and manufacturing requirements.</li>
<li>Interact with client companies in a professional manner. Proactively communicate with client companies to ensure an ongoing two-way exchange of information.</li>
<li>Generate innovative concepts for new medical device designs to satisfy customer and clinical requirements. Lead and participate in concept generation activities, including brainstorming sessions. Refine, rate, rank and/or otherwise assess concepts.</li>
<li>Utilize SolidWorks to develop detailed 3-D CAD models and drawings, including component, subassembly, and top-level drawings.</li>
<li>Investigate and evaluate existing technology for application to projects.</li>
<li>Design and implement new methodologies, materials, machines, processes or products as required to achieve product development goals.</li>
<li>Produce prototype devices for testing and evaluation. Work with internal and/or external resources to produce prototype device components. Assemble and/or evaluate prototype devices.</li>
<li>Conduct bench and/or animal feasibility studies.</li>
<li>Conduct product verification and validation testing to demonstrate product safety and efficacy. Determine what testing is required to satisfy product requirements, to investigate potential failure modes, and to otherwise address the project design inputs. Develop protocols, plan testing, and perform or monitor testing. Utilize statistical methods as required to plan testing and to analyze test results. Write test reports which draw conclusions from the results.</li>
<li>Conduct risk analyses. Conduct and document Failure Mode and Effects Analyses.</li>
<li>Perform tolerance analysis of components and assemblies to ensure proper fit and functionality.</li>
<li>Coordinate activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet customer expectations.</li>
<li>Maintain detailed essential product and process documentation throughout all phases of research and development. Maintain Design History Files (DHFs). Ensure that DHFs are accurate, complete and well organized.</li>
<li>Prepare documentation release packages, including detail drawings, bills of material, and/or procedures. Approve Document Change Orders (DCOs) and obtain approvals from others as required.</li>
<li>Ensure that all work satisfies the requirements of client companies Quality Systems, with particular emphasis on Design Control.</li>
<li>Conduct and document Design Reviews.</li>
<li>Participate in Material Review Board activities. Make decisions regarding product and material discrepancies and initiate appropriate action to prevent subsequent problems or discrepancies.</li>
<li>Date, sign and have witnessed all documents that may establish inventorship dates.</li>
<li>Some local travel (i.e. by car). Occasional long-distance travel (i.e. by plane).</li>
</ul>
 OTHER DUTIES AND RESPONSIBILITIES 
<ul>
<li>Any other duties as assigned.</li>
</ul>
 REQUIRED COMPETENCIES Customer Focus 
<ul>
<li>Provide professional, reliable and prompt service to client companies and coworkers. Work in partnership with others to meet or exceed customer expectations. Interpret customers needs and take appropriate action. Follow through on customers inquiries in a professional and timely manner.</li>
</ul>
Management of Resources 
<ul>
<li>Work in an organized and time effective manner. Proactively seek out relevant reference materials as necessary. Take initiative for self-development. Prioritize tasks effectively. Demonstrate initiative and innovation in the use of available resources.</li>
</ul>
 Communication Skills 
<ul>
<li>Write and speak in a concise, technically accurate, timely, and professional manner. Exhibit strong verbal presentation and negotiation skills. Interact with client company personnel in a positive and professional manner. Express ideas, recommendations and solutions clearly, logically and concisely in both written and verbal communications. Demonstrate tact and diplomacy in communications. Demonstrate active listening skills and ability to resolve discrepancies with customers.</li>
</ul>
 PREPARATION, KNOWLEDGE, SKILLS &amp; ABILITIES: 
<ul>
<li>Bachelor's degree in Mechanical or Biomedical Engineering is required. Masters degree in engineering, management or business is a plus.</li>
<li>Some prior medical device product design and development experience is required.</li>
<li>Demonstrated ability to bring products from concept to market.</li>
<li>Ability to interact with client companies in a professional manner.</li>
<li>SolidWorks 3D CAD proficiency is required.</li>
<li>Knowledge of probability and statistics.</li>
<li>Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.</li>
<li>Familiarity with FDA QSR and ISO 13,485 medical device regulations.</li>
<li>Depth of knowledge in one or more clinical areas.</li>
<li>Depth of knowledge in one or more medical device product areas.</li>
<li>Depth of knowledge in one or more technical areas, for example finite element analysis.</li>
</ul>
 SUPERVISORY RESPONSIBILITY: 
<ul>
<li>May direct the work of other people, and may have direct reports.</li>
</ul>
 WORKING CONDITIONS/PHYSICAL DEMANDS: 
<ul>
<li>Must be able to move throughout office and laboratory space, using a complete variety of office equipment and laboratory machinery and tools. Must be able to lift more than 50 pounds and stand for extended periods of time. Must tolerate exposure to chemicals found in a laboratory environment.</li>
<li>The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.</li>
<li>External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis.</li>
</ul>
 TRAINING: 
<ul>
<li>Training requirements are defined in the Sage Training Log.</li>
</ul>

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