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job_organization_name

city

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<h3>Job Description</h3>
Job Description
Company Information Our client is an industry-leading laboratory equipment manufacturer best known for its high-quality centrifuges and incubators used in clinical, blood processing, and research laboratories. Additionally , offering special centrifuges and other equipment for integration with laboratory automation systems.
Role Overview&nbsp; The Field Service Engineer will carry out repairs, calibrations, validations on centrifuges, incubators and other proprietary/lab equipment. Travel throughout St. Louis, Missouri, extending to Chicago in order to meet customer product needs is essential; whilst maintaing an excellent level of customer satisfaction on sites that are assigned. The FSE must be comfortable with flights to ensure that services are met within a timely fashion. · Carry out calibrations, validations and repairs on centrifuges, incubators, and other proprietary products/lab equipment. · Identify, Troubleshoot and Repair customer equipment in a cost-effective manner · Military, clinical engineering, biomedical, mechanical experience in the field · Maintain an excellent level of customer satisfaction on sites that are assigned to you
Person specification · Field service experience with electrical/electronic schematics and/or military electronics · Strong diagnostic skills, within the bio-medical field/clinical engineering/military bio-medical repair · Ability to utilize electrical and mechanical testing equipment · Attentive to detail · Prioritization abilities to evaluate demands daily · Professional demeanour with customers · Clear communication skills · Military, clinical engineering, biomedical, mechanical experience in the field · (Preferred) Experience with small electric testing tools DVM, ammeters, oscilloscopes, etc
Company DescriptionZenopa is a service organisation that provides flexible, rapid and effective recruitment solutions to our clients. We specialise in the commercial side of the healthcare industry, and recruit for various markets including, Pharmaceutical, Medical, Scientific, Animal Health, Dental, Engineering, Consumer Health, and Medical Communications. Zenopa has an excellent reputation spanning over 25 years, being awarded 'Great Place to Work' four years in a row, and is one of the leading recruitment agencies. Based in High Wycombe, Buckinghamshire and Charlotte, NC the company has demonstrated fantastic growth over the past 10 years. 
<h3>Company Description</h3>
Zenopa is a service organisation that provides flexible, rapid and effective recruitment solutions to our clients. We specialise in the commercial side of the healthcare industry, and recruit for various markets including, Pharmaceutical, Medical, Scientific, Animal Health, Dental, Engineering, Consumer Health, and Medical Communications. Zenopa has an excellent reputation spanning over 25 years, being awarded 'Great Place to Work' four years in a row, and is one of the leading recruitment agencies. Based in High Wycombe, Buckinghamshire and Charlotte, NC the company has demonstrated fantastic growth over the past 10 years.

Field Service Engineer

<h3>Job Description</h3>
Job Description
Li-ion Battery Engineer
&nbsp;
Job Title: LI-Ion Battery Engineer Location: Pittsburgh, PA Employment Type: Part-Time Company: Power 3D – Advanced Battery Technology Startup
&nbsp;
About Us:
Power 3D, a Carnegie Mellon University spinout, is reinventing the way batteries are built. We’re pioneering a revolutionary approach that uses 3D printing to manufacture high-performance cathodes, combined with semiconductor fabrication processes to construct the full battery architecture—including current collectors, separators, and packaging layers. Our mission is to enable compact, high-energy-density batteries for the next generation of consumer electronics, wearables, and medical devices.
The company recently received an NSF SBIR to develop a prototype and needs help on the battery aspects of our battery.
&nbsp;Position Overview:Power3D Inc., is seeking a highly motivated battery engineer to develop high-capacity Li-ion batteries using innovative 3D electrode architectures. This exciting opportunity offers the chance to conduct cutting-edge research in a dynamic and collaborative environment. This is a part time position&nbsp;The successful candidate will lead research efforts in cathode manufacturing, battery assembly, characterization, and electrochemical performance testing (EIS, cyclic tests, etc.) to achieve project-defined capacity targets.&nbsp; Responsibilities will include the packaging of small form-factor batteries and the characterization of electrodes using advanced techniques such as SEM, FIB, XRD, and TEM. Experience in battery assembly and electrochemical characterization is required. Prior experience in microfabrication and nanoparticle 3D printing is highly desirable, as is familiarity with battery simulation tools. A strong drive to explore new engineering challenges and develop innovative scientific solutions is essential.&nbsp;Importantly, the candidate must have excellent verbal and written communication skills, and experience with research in Li-ion battery manufacturing and testing. Salary will be commensurate with research experience and technical background. The company is incubated in the Panat lab at Carnegie Mellon University, that works in the area of energy materials, nanoparticle 3D printing and biomedical devices.&nbsp;Key responsibilities:
<ul>
<li>Conduct research on Li-ion batteries, encompassing
<ul>
<li>o Fabrication of electrodes using additive manufacturing techniques.</li>
<li>o Characterization of electrodes using SEM, FIB, XRD, and TEM.</li>
<li>o Development of packaging technologies for integrating batteries with wearable devices.</li>
<li>o Battery stack assembly and testing via standard methods (e.g., cyclic tests, EIS).</li>
<li>o Simulation of 3D Li-ion battery stacks using software packages like COMSOL.</li>
</ul>
</li>
<li>Supervise and evaluate the technical work of other team members.</li>
<li>Prepare and deliver verbal presentations, quarterly progress reports, and presentations for potential investors in this technology.</li>
</ul>
&nbsp;Qualifications:
<ul>
<li>M.S. or Ph.D. (preferred) in Mechanical Engineering, Materials Science and Engineering, Chemical Engineering, or a related field.</li>
<li>Demonstrated experience in Li-ion battery research.</li>
<li>Proficiency in microfabrication and familiarity with characterization tools such as SEM, FIB, XRD, and TEM.</li>
<li>Excellent verbal and written English communication skills.</li>
<li>Ability to work independently and collaboratively within a team environment.</li>
<li>Commitment to meeting research project deadlines.</li>
</ul>
&nbsp;
Preferred Qualifications:
<ul>
<li>Familiarity with nanoparticle 3D printing.</li>
<li>Familiarity with battery simulation tools (e.g., COMSOL).</li>
<li>Familiarity with grant proposal writing.</li>
</ul>
Why Join Us:
<ul>
<li>Be part of a pioneering team developing a breakthrough battery technology.</li>
<li>Work in a collaborative, mission-driven environment.</li>
<li>Competitive compensation, equity, and benefits.</li>
<li>Opportunity for career growth as we scale rapidly.</li>
</ul>
Apply Now
Send your resume and a short cover letter to <a href="mailto:power3d.battery@gmail.com" target="_blank">power3d.battery@gmail.com</a> with the subject line "Battery Engineer – Application." We’d love to hear why you’re excited to join our journey.
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Li-ion Battery Engineer- Power 3D Advance Battery Technology Start-Up

<h3>Job Description</h3>
Job DescriptionDescription:
This systems engineer role provides an opportunity to work with a highly cross-functional team including scientists/engineers, clinical/regulatory and marketing staff to contribute towards successful ophthalmic medical products. The nature of projects may range from new product development, sustaining and improving existing products. The successful candidate will provide technical leadership in systems engineering related areas including system requirements specification, system architecture and design, and system verification and validation. The systems engineer also assumes the following responsibilities as required: support product sustaining, improve product reliability and quality, and conduct testing to meet medical device standards. Strong grasp on the fundamentals of optical imaging system design, pilot production experience, team-player with effective communication skills, open-mindedness to new ideas and methodical problem-solving skills are some of the key attributes that are expected from the position. Senior or Staff title will depend on the candidate’s experience and qualifications.
 
Essential Responsibilities
<ul>
<li>Participate in new product development and work with a highly cross-functional team through various stages of product development.</li>
<li>Plan and conduct in-depth reviews, testing and verifications/validation of product features. Conduct design transfer to manufacturing team.</li>
<li>Perform trade-off analysis of technology, systems architecture, and design alternatives through simulation, test, and measurements.</li>
<li>Early identification of technical risks and developing a plan for addressing these issues.</li>
<li>Provide technical leadership in qualifying new parts/modules and confirming system performances to support product sustaining.</li>
<li>Lead product troubleshooting to improve product quality/reliability.</li>
<li>Identify and build improvements or enhancements to existing products.</li>
<li>Other duties as assigned.</li>
</ul>
Requirements:
<ul>
<li>PhD in optics, biomedical instrumentation, electrical engineering, physics, bioengineering or related field plus 3 years of relevant work experience; or MS in related engineering field plus 5 years of relevant work experience.</li>
<li>Track record of delivering complex medical devices to market as systems engineer and good documentation with the compliance to medical device design control standard, e.g. ISO 13485 and FDA 21 CFR 820.30.</li>
<li>Hands-on experience of developing a new medical product through various stages of product development process.</li>
<li>Familiar with system safety and EMC testing (IEC 60601-1 and IEC 60601-1-2), environmental testing, and reliability-related testing etc.</li>
<li>Strong understanding of integrated optical imaging systems involving opto-mechanics, electronics, basic image processing and related sub-systems and technologies.</li>
<li>Strong problem solving and trouble shooting skills.</li>
<li>A self-motivated team player who is adaptable and comfortable working in a dynamic, high-paced environment. </li>
<li>Experience in developing imaging devices and products that required synchronized data collection and instrument control.</li>
<li>Familiar with ISO 15004 is a plus.</li>
<li>Experience in pilot production process for medical devices.</li>
<li>Experience in collaborating with marketing, doctors and clinical researchers.</li>
<li>Mathematical modeling skills using MATLAB or other tools</li>
</ul>

Staff System Engineer

<h3>Job Description</h3>
Job Description
Position Description (Principle Duties and Responsibilities)
<ul>
<li>Designing and developing new products that meet functional, safety, and cost requirements.</li>
<li>Specifying and documenting precise product functional requirements.</li>
<li>Testing and integrating components to deliver optimized final product designs.</li>
<li>Evaluating product effectiveness, safety, reliability, and cost to ensure compliance with standards.</li>
<li>Developing and executing product specifications, fitness-for-use testing, and process validation plans.</li>
<li>Creating and reviewing material part specifications and bills of materials (BOMs).</li>
<li>Collaborating with internal manufacturing partners, contract manufacturers, designers, and product specialists to ensure manufacturability and quality.</li>
<li>Utilizing CAD/CAE systems to model designs, produce engineering drawings, and validate design solutions.</li>
<li>Supporting continuous improvement initiatives to enhance product development processes.</li>
</ul>
What you need
<ul>
<li>Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related technical discipline required.</li>
<li>Minimum of 2+ years of engineering experience in product design, validation, or development.</li>
<li>Strong proficiency in CAD/CAE software (e.g., SolidWorks, Creo, CATIA, or equivalent).</li>
<li>Strong problem-solving and analytical skills.</li>
<li>Experience with testing, validation, and process development.</li>
<li>Excellent communication and collaboration skills.</li>
<li>Experience in the medical device, life sciences, or highly regulated industry.</li>
<li>Knowledge of design controls, FDA regulations, or ISO standards.</li>
<li>Familiarity with GD&amp;T (Geometric Dimensioning and Tolerancing).</li>
<li>Experience with manufacturing processes (e.g., machining, molding, assembly).</li>
<li>APQP, DFMEA, PFMEA, or Six Sigma certification a plus.</li>
</ul>
Company DescriptionWhether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management. Benefits: 401(k) matching Comprehensive dental, vision, and health insurance Flexible schedule options Health savings account Life insurance Paid time off Professional development assistance Employee assistance and discount programs Referral program Retirement plan Tuition reimbursement iMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential. Experience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference! Contact us today to learn more: *** Grand Rapids, Michigan: 616.254.8586 *** Tampa, Florida: 813.463.8850 *** <a href="http://www.impactbusinessgroup.com" target="_blank">www.impactbusinessgroup.com</a> *** Chat with us live: <a href="https://lc.chat/now/8608604/" target="_blank">https://lc.chat/now/8608604/</a> 
<h3>Company Description</h3>
Whether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management.\r\n\r\nBenefits:\r\n401(k) matching\r\nComprehensive dental, vision, and health insurance\r\nFlexible schedule options\r\nHealth savings account\r\nLife insurance\r\nPaid time off\r\nProfessional development assistance\r\nEmployee assistance and discount programs\r\nReferral program\r\nRetirement plan\r\nTuition reimbursement\r\n\r\niMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential. \r\n\r\nExperience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference!\r\n\r\nContact us today to learn more:\r\n*** Grand Rapids, Michigan: 616.254.8586\r\n*** Tampa, Florida: 813.463.8850\r\n*** <a href="http://www.impactbusinessgroup.com" target="_blank">www.impactbusinessgroup.com</a>\r\n*** Chat with us live: <a href="https://lc.chat/now/8608604/" target="_blank">https://lc.chat/now/8608604/</a>

Product Development Engineer (Medical Device) - 26624

<h3>Job Description</h3>
Job DescriptionBenefits: 
<ul>
<li>401(k)</li>
<li>401(k) matching</li>
<li>Company parties</li>
<li>Competitive salary</li>
<li>Dental insurance</li>
<li>Free food &amp; snacks</li>
<li>Health insurance</li>
<li>Opportunity for advancement</li>
<li>Paid time off</li>
<li>Vision insurance</li>
</ul>
 BridgeMed Solutions, Inc is seeking a Mechanical Engineer. Training will be provided. Are you passionate about pioneering medical innovations? Join our dynamic team at BridgeMed Solutions, where we're revolutionizing healthcare through cutting-edge technology. We are an Irvine-based Contract Manufacturing Organization that is ISO and FDA certified. We are a privately owned company that specializes in tissue heart valve technology. We additionally custom produce transcatheter valves for various clients. Embrace the opportunity to make a meaningful impact on patient care while collaborating with talented professionals in a fast-paced startup environment. Apply now and be part of our journey towards transforming lives. Job Title: Mechanical Engineer Experience: +3 years of experience in Engineering, experience in medical device is a plus. Location: Local candidates only (must live in Orange County) Job Type: Full Time, 100% In-House Salary: $22-$30 DOE (Non-Exempt) Benefits: PTO, Sick days, Holiday Pay, 401k, Health-Vision-Dental Coverage, Free Lunch Fridays, Professional Development Opportunities Principal Duties and Responsibilities 
<ul>
<li>Lead and manage engineering projects from concept through to prototype and market release, ensuring alignment with regulatory requirements (FDA, ISO).</li>
<li>Collaborate with cross-functional teams, including engineering, quality assurance, and operations, to develop project plans, schedules, and risk assessments.</li>
<li>Develop and review technical documentation, including design specifications, test protocols, and validation reports, to support product development and regulatory submissions.</li>
<li>Oversee the execution of validation activities for new and legacy medical devices, ensuring they meet intended performance and safety standards.</li>
<li>Facilitate root cause investigations for non-conformance issues, implementing corrective actions and driving continuous improvement initiatives.</li>
<li>Project and client management is a must</li>
</ul>
Skills and Qualifications 
<ul>
<li>Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, or related field).</li>
<li>Minimum of 3 years of experience in Engineering, medical device industry preferred with a strong understanding of FDA regulations and ISO standards.</li>
<li>Proven experience in project management and cross-functional team collaboration.</li>
<li>Strong analytical skills with the ability to conduct detailed assessments and develop effective solutions.</li>
<li>Excellent communication skills, both written and verbal, with the ability to present complex information clearly to stakeholders.</li>
<li>Proficient in Microsoft Office and engineering design software; familiarity with statistical analysis tools (e.g., Minitab) is a plus.</li>
<li>Detail-oriented with strong organizational skills, capable of managing multiple projects in a fast-paced environment.</li>
</ul>

Engineer (Mechanical - Medical Device)

<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>

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