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<h3>Job Description</h3>
Company Overview:&nbsp;
Digital Health Solutions is a premier consulting company dedicated to providing comprehensive solutions to medical device companies. We specialize in helping our clients navigate the complexities of IEC 62304 and ISO 13485 compliance. Our team of skilled professionals is committed to delivering the highest level of service, ensuring that our clients' products are both safe and effective for their end users.&nbsp;
We are currently seeking a talented Senior Systems Engineer to join our dynamic team. The ideal candidate will have extensive experience in system engineering, requirement management and risk management, along with hands-on electrical engineering skills, including electrical component analysis with review of datasheet, board bring-up, troubleshooting, and rework/soldering. This is a multidisciplinary role requiring understanding of the design controls process for medical device industry.&nbsp;
Responsibilities:&nbsp;
<ul>
<li>Translates voice of customer into user needs for medical device products.&nbsp;&nbsp;</li>
<li>Develops system and subsystem requirements.&nbsp;</li>
<li>Works closely with multi-disciplinary engineering team, including hardware and software engineers, to design, integrate, and verify embedded systems.&nbsp;</li>
<li>Participates in hardware and software design and development activities, working with engineers to ensure the design will meet requirements.&nbsp;</li>
<li>Participates in safety and cybersecurity risk analysis activities.&nbsp;</li>
<li>Ensures the requirements may be verified in compliance with design controls and other QMS SOPs.&nbsp;</li>
<li>Coordinates system verification and validation activities, including integration of mechanical, electrical, and software components.&nbsp;</li>
<li>Collaborate with cross-functional teams, including software development, quality assurance, and regulatory affairs, to ensure secure and compliant system development processes.&nbsp;</li>
<li>Reviews and develops technical documentation to ensure the planned activities match the system and subsystem verification and validation approach.&nbsp;</li>
<li>Leads requirements verification and validation activities by actively engaging in the technical work, supervising V&amp;V engineers as needed.&nbsp;</li>
<li>Leads and reviews reports from external testing including 60601, biocompatibility, FCC, usability, and cybersecurity&nbsp;</li>
<li>Participates in Design Reviews and leads technical reviews&nbsp;</li>
<li>Coordinates and presents technical data, analyses, and status at reviews (internal and external).&nbsp;</li>
<li>Manages technical and schedule balance while coordinating with the project manager and functional leads to ensure the planned approach meets schedule constraints.&nbsp;</li>
<li>Helps grow the organization by participating in interview process for engineers of various disciplines, working closely with DHS senior leadership&nbsp;</li>
<li>Stay current with industry trends, emerging threats, and best practices in medical devices to continuously improve our services and maintain our competitive edge.&nbsp;</li>
<li>Performs other tasks as required.&nbsp;</li>
</ul>
Qualifications:&nbsp;
<ul>
<li>Bachelor’s degree in Electrical Engineering, Biomedical Engineering, Systems Engineering, or related field. Master’s degree preferred.&nbsp;</li>
<li>2 to 5 years of experience in systems engineering, with a focus on medical devices.&nbsp;</li>
<li>Strong knowledge of IEC 62304, IEC 60601, ISO 13485, ISO 14971, 21 CFR 820.30, ANSI/AAMI SW96, FDA Guidance for Cybersecurity in Medical Devices and other relevant medical device regulations and standards.&nbsp;</li>
<li>Demonstrated experience in conducting risk assessments and developing risk mitigation strategies for complex systems. Knowledge of security risk management activities preferred.&nbsp;&nbsp;</li>
<li>Excellent problem-solving skills and the ability to work independently or as part of a team.&nbsp;</li>
<li>Strong communication skills, both written and verbal, with the ability to effectively convey complex technical concepts to non-technical stakeholders.&nbsp;</li>
</ul>
What We Offer:&nbsp;
<ul>
<li>Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.&nbsp;</li>
<li>Opportunity to work with cutting-edge technology in the medical device industry.&nbsp;</li>
<li>A supportive, collaborative work environment that fosters professional growth and development.&nbsp;</li>
<li>The chance to make a meaningful impact on the safety and effectiveness of medical devices, ultimately improving patients' lives.&nbsp;</li>
</ul>

Senior Systems Engineer

<h3>Job Description</h3>
Job Summary
The Development Engineer leads or participates on teams responsible for the design and development of surgical implants and instruments from concept through launch.&nbsp;The focus of these development projects has a heavy emphasis on the individualized treatment of patients on behalf of a requesting surgeon.&nbsp;The role also encompasses implementation of improvements and value engineering to existing patient specific product offerings and services, support of the development of the quality system and other company initiatives.&nbsp;
 
Responsibilities
<ul>
<li>Adhere to Onkos Core Beliefs, Code of Business Conduct, all regulatory requirements and quality standards.</li>
<li>Support company advocacy initiatives to help raise awareness of sarcoma and pediatric cancer and drive positive change that will impact the lives of cancer patients.</li>
<li>Prepare and manage to comprehensive project plans, resource requirements, project budgets, timelines, etc.</li>
<li>Interface with sales force, surgeons, and other stakeholders to understand customer needs in order to define design inputs, draft product performance requirements, and draft surgical techniques.</li>
<li>Utilize CAD software to model designs and detail engineering drawings, optimizing designs for quality, manufacturability, inspectability, and cost.</li>
<li>Facilitate manufacture of prototypes and test articles.</li>
<li>Develop and execute product test plans ranging from early bench testing/prototype evaluation to final validation and verification.</li>
<li>Partner with regulatory team to fulfill all requirements for regulatory submissions and reports.</li>
<li>Generate design controls, risk management documentation, and other technical memos, conducting root cause and engineering analyses as necessary.</li>
<li>Support quality, regulatory, and marketing initiatives that require engineering assistance, analyses and quantitative assessments of markets and products.</li>
<li>Assist in developing innovative manufacturing and processing techniques and/or seek out new technologies for materials and processing through 3rd party relationships.</li>
<li>Consult with surgeons and sales force to identify potential solutions for difficult patient cases.</li>
</ul>
 
Requirements
<ul>
<li>Passion to find solutions to our patients’ unmet clinical needs and to advocate for their cause.</li>
<li>Bachelor’s degree in engineering or life sciences discipline. Mechanical or Biomedical Engineering preferred.</li>
<li>3+ years of product development experience in the medical device field, preferably related to orthopedics.&nbsp;Experience working with surgeons on product design a strong plus.</li>
<li>Ability to apply engineering principles to solve problems and develop new products and techniques.</li>
<li>Demonstrated ability with CAD software.&nbsp;SOLIDWORKS and NX preferred. </li>
<li>Must be self-motivated, able to work independently, and thrive in a fast-paced dynamic environment.</li>
<li>Strong attention to detail, interpersonal skills, and oral and written communication skills.</li>
<li>Must be willing to attend and participate in cadaveric product evaluations and attend surgery for observation and/or technical support. </li>
<li>Travel:&nbsp;Up to 5%</li>
</ul>
 
About Onkos
At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause.
 
At Onkos Surgical, we exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients.
 
At Onkos Surgical, we will:
<ul>
<li>Find solutions to our patients’ unmet clinical needs and advocate for their cause.</li>
<li>Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently.</li>
<li>Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance.</li>
<li>Fulfill our employees’ desire to make a difference in the lives of the patients they serve while achieving their own professional growth.</li>
<li>Deliver value to our customers and shareholders.</li>
</ul>

Product Development Engineer

<h3>Job Description</h3>
Location:&nbsp;Woburn, MA
 
Vaxess is developing a pipeline of next-generation vaccines and therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the self-applied patch enables up to two weeks of sustained delivery. The platform combines high temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.&nbsp;
The Senior Mechanical Engineer is a hands-on position involving designing, building, and maintaining automated production equipment throughout its lifecycle. This role will be responsible for design, assembly, installation, qualification, ongoing maintenance, and optimization of automated production systems requiring expert troubleshooting of mechanical assemblies and systems, performing root cause analysis, and implementing corrective actions to ensure efficient, reliable manufacturing operations.&nbsp;
Working at Vaxess is cross-disciplinary, integrating chemistry, biology, immunology, mechanical, biomedical, and chemical engineering to address important unmet medical needs. We are seeking a talented, collaborative, and highly motivated individual to join our team. This is a unique opportunity to be part of an emerging startup and significantly influence the strategic growth and future direction of the company as we bring innovative technology to the global vaccine and therapeutic market.
 
Responsibilities
<ul>
<li>Design, implement, and maintain novel automated systems and solutions that contribute to current manufacturing and scale up of manufacturing operations to eventual commercialization.</li>
<li>Manage external vendors to develop plans, evaluate proposals, and ensure delivery of projects in-scope, within budget, and on time.</li>
<li>Document equipment and procedures though User Requirements Specifications, detailed mechanical, electrical, and assembly drawings, and use and maintenance SOPs. Contribute to the implementation and maintenance of the Quality Management System.</li>
<li>Collaborate closely with cross-functional teams to support product development and manufacturing activities, and to identify and resolve manufacturing issues.&nbsp;</li>
<li>Contribute to continuous improvement to increase safety, quality, and efficiency of manufacturing.</li>
</ul>
 
Qualifications
<ul>
<li>BS or advanced degree in Mechanical Engineering or a related discipline.&nbsp;</li>
<li>At least 10 years of experience in designing, building, installing, qualifying, and maintaining automated systems for high volume medical device&nbsp; manufacturing.&nbsp;</li>
<li>Experience writing and executing IQ, OQ and PQ protocols.&nbsp;&nbsp;</li>
<li>Experience developing URS, FAT and SAT documents for automated equipment</li>
<li>3D CAD (SolidWorks or similar) as well as Mechanical design of fixtures, assemblies and equipment.&nbsp;</li>
<li>Understanding and working knowledge of mechanical linkages, power transmissions and practices.&nbsp;</li>
<li>Understanding of diverse fabrication techniques, manufacturing processes, and Design for Manufacturability&nbsp;</li>
<li>Excellent time and project management skills and proven ability to meet goals and deadlines.</li>
<li>Demonstrated abilities to learn new skills and fields, creatively solve challenging technical problems, think independently, and work collaboratively in diverse multidisciplinary teams.</li>
<li>Entrepreneurial spirit and drive to positively impact global human health.</li>
</ul>

Senior Mechanical Engineer

<h3>Job Description</h3>
Principal Systems Engineer
Location: Andover, MA (In-person)
 
Company Overview
Digital Health Solutions (DHS) is a premier consulting firm dedicated to advancing medical device innovation. We partner with companies across the medical technology spectrum to deliver safe, effective, and compliant solutions. With deep expertise in IEC 62304, ISO 13485, and FDA/EU regulatory frameworks, DHS helps clients accelerate product development while ensuring patient safety and clinical impact remain at the core. Our mission is simple yet powerful: to guide the development of medical technologies that improve and save lives.
 
Position Overview
We are seeking an accomplished Principal Systems Engineer to join our growing team. This role is ideal for a highly experienced systems thinker who thrives at the intersection of engineering, clinical application, and regulatory compliance. The Principal Systems Engineer will lead complex projects across Class II and III medical devices, bringing together cross-functional teams to deliver innovative solutions in areas such as neurostimulation, cardiac support, and medical imaging.
At DHS, you won’t just contribute technical, you will shape strategy, mentor emerging engineers, and influence the next generation of patient-focused technology. This is a hands-on leadership role where you’ll translate clinical needs into actionable requirements, architect and validate systems, and drive design control excellence from concept through commercialization.
We are looking for a candidate who combines technical depth, regulatory fluency, and leadership presence. The ideal candidate is someone who can balance innovation with compliance, build consensus across diverse stakeholders, and drive projects to successful completion in fast-paced environments.
 
Key Responsibilities
<ul>
<li>Lead systems engineering activities across the full product lifecycle, from concept through verification, validation, and commercialization.</li>
<li>Translate user and clinical needs into system, subsystem, and component requirements while maintaining rigorous traceability.</li>
<li>Participate in hardware and software design and development activities, working with engineers to ensure the design will meet requirements.</li>
<li>Ensure requirements can be verified in compliance with design controls and other QMS SOPs.</li>
<li>Architect system-level solutions, define interfaces, and guide trade-off analyses to achieve optimal design outcomes.</li>
<li>Oversee risk management activities (HA, FMEA, risk-benefit analysis) ensuring compliance with ISO 14971 and related standards.</li>
<li>Direct verification and validation strategies, author test protocols/reports, and coordinate testing with external labs.</li>
<li>Drive design control documentation and ensure adherence to ISO 13485, IEC 60601, IEC 62304, and FDA/EU regulations.</li>
<li>Collaborate cross-functionally with clinical, quality, regulatory, and manufacturing teams to resolve conflicts and ensure alignment.</li>
<li>Mentor junior engineers, fostering professional growth and building DHS’s technical leadership bench.</li>
<li>Contribute to program management activities including project planning, deliverable tracking, and executive reporting.</li>
<li>Support business development efforts through technical input to proposals, client engagement, and thought leadership.</li>
</ul>
 
Preferred Qualifications
<ul>
<li>Master’s degree in Biomedical, Electrical, Systems, or related Engineering field (PhD a plus).</li>
<li>10+ years of experience in systems engineering within Class II/III medical devices.</li>
<li>Proven track record in requirements management, system architecture, and verification/validation.</li>
<li>Strong knowledge of regulatory compliance (FDA 21 CFR Part 11/820, EU MDR, ISO 13485, IEC 60601, IEC 62304, ISO 14971).</li>
<li>Experience leading cross-functional teams, managing CAPAs, and closing complex regulatory gaps.</li>
<li>Skilled in tools such as JIRA, Confluence, and test management platforms.</li>
<li>Strong interpersonal skills with the ability to communicate effectively across technical and non-technical audiences.</li>
</ul>
 
What We Offer
<ul>
<li>Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.</li>
<li>The opportunity to work on cutting-edge medical technologies that directly improve patient lives.</li>
<li>Exposure to a broad range of projects and modalities, from implantable devices to advanced imaging systems.</li>
<li>Mentorship and collaboration with leading experts in systems engineering, regulatory affairs, and product development.</li>
<li>A role where your technical leadership and strategic insight shape both client success and DHS’s growth.</li>
<li>The satisfaction of delivering solutions that balance innovation, compliance, and patient safety—making a tangible impact in healthcare.</li>
</ul>

Principal Systems Engineer

<h3>Job Description</h3>
Job Description
This is a remote position.
 We are seeking a talented and self-driven Quality Engineer to ensure all products, processes, and quality systems within the organization comply with applicable medical device regulations and global standards. This role is integral to driving quality excellence across the product lifecycle from design and development through manufacturing, validation, and post-market support. The ideal candidate possesses a strong technical foundation, meticulous attention to detail, and a proactive approach to problem-solving and continuous improvement. This individual will collaborate cross-functionally with R&amp;D, Manufacturing, Regulatory, and Supplier Quality teams to uphold the highest levels of product safety, compliance, and performance. Key Responsibilities Support design control activities, ensuring design inputs, outputs, verification, and validation meet regulatory and organizational requirements. Participate in risk management activities (ISO 14971), including FMEA and hazard analysis. Review and maintain Design History Files (DHF), technical documentation, and change control records. Collaborate with R&amp;D, Manufacturing, and Regulatory teams to ensure compliant design transfer into production. Support and lead process validation activities (IQ/OQ/PQ), ensuring adherence to validation master plans. Evaluate nonconformances and conduct root cause investigations using structured problem-solving tools (5 Whys, Fishbone, etc.). Drive Corrective and Preventive Actions (CAPA) to timely closure and verify effectiveness. Monitor production processes and quality metrics, identifying trends and improvement opportunities. Support equipment qualification, calibration, and validation maintenance to ensure compliance. Participate in supplier qualification, performance monitoring, and audits to verify compliance with quality requirements. Manage Supplier Corrective Action Requests (SCARs) and collaborate with suppliers to resolve quality issues. Review incoming inspection results, PPAP documentation, and supplier process records. Maintain and continuously improve the Quality Management System (QMS) in compliance with 21 CFR Part 820, ISO 13485, MDSAP, and EU MDR. Prepare for and support internal, external, and regulatory audits, including documentation and response management. Create, revise, and implement Standard Operating Procedures (SOPs) and work instructions. Participate in change control reviews to ensure ongoing product and process compliance. Utilize data analysis and statistical tools (SPC, Cpk, Minitab, etc.) to drive process and product improvements. Apply Lean Six Sigma methodologies to enhance efficiency and reduce waste. Contribute to cross-functional projects focused on risk mitigation and operational excellence. Support training and mentoring of cross-functional teams on quality principles, tools, and regulatory expectations. Must-Have Qualifications Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, or a related scientific discipline. Experience in a regulated medical device environment with working knowledge of FDA QSR, ISO 13485, and ISO 14971. Hands-on experience in process validation, CAPA, risk management, nonconformance investigations, and audit support. Familiarity with statistical analysis tools and data-driven quality decision-making. Strong communication, documentation, and cross-functional collaboration skills. Certification in Lean Six Sigma, ASQ CQE, or a similar credential preferred. Preferred Qualifications Working knowledge of MDSAP, EU MDR, and other international regulatory frameworks. Proficiency with electronic QMS platforms (e.g., MasterControl, TrackWise, Veeva). Experience with combination products, sterilization validation, or cleanroom manufacturing environments. This is intended for inclusion in Pharmavise’s talent database to build a qualified pool of professionals for future medical device client requisitions.

Quality Engineer

<h3>Job Description</h3>
Job DescriptionSalary: 
Position Description
The Clinical Engineer is a skilled data-savvy contributor who receives and organizes inbound clinical data in various formats from multiple research sites engaged in Carlsmed-sponsored studies. The role involves receiving, vetting, and forwarding medical images to measurement services and parsing large data sets into subsets for analysis.
 
Key Responsibilities
<ul>
<li>Receiving and preparing incoming data from multiple clinical studies</li>
<li>Sorting and organizing information in various formats, including numerical values, categorical attributes, medical imaging, patient surveys, and free-text medical notes</li>
<li>Organizing and forwarding medical images to measurement services</li>
<li>Collating and formatting data for statistical analysis</li>
<li>Creating tables, charts, and figures for internal and external reports.</li>
<li>Preparing PowerPoint presentations and manuscript materials</li>
</ul>
 
Skills
<ul>
<li>Data organization: tabulating, sorting, and analyzing scientific data</li>
<li>Advanced user of MS-Office software (Word, Excel, PowerPoint)</li>
<li>Desired: Proficient with Python for data cleaning and formatting</li>
<li>Effective communication and presentation skills.</li>
</ul>
<ul>
<li>Continuous issue detection and resolution.</li>
</ul>
 
Qualifications
<ul>
<li>BS degree in a technical field such as Engineering, Life Sciences, Computer Sciences, Mathematics or related medical/scientific field. MS degree preferred.</li>
<li>Experience with digital image software, preferably medical imaging software</li>
<li>Highly desired: previous contributions to biomedical or biological studies</li>
<li>Highly desired: knowledge/experience in spine/orthopedics</li>
</ul>
Equal Opportunity Employer
Carlsmed is an equal-opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Carlsmed is committed to providing reasonable accommodation for candidates with disabilities in our recruitment process. If you need any assistance or accommodation due to a disability, please let us know.
 
Compensation
We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental and vision insurance premiums, a 401(k) plan with employer matching, and unlimited PTO. The expected pay range for this position is $95,000 - $120,000. Compensation may vary based on related skills, experience, and relevant key attributes.

Clinical Engineer

<h3>Job Description</h3>
Job Description
Role: Manufacturing Engineer Location: Plymouth, MN - 55442 Duration: 6 Months Shift Timings: 8:00 am to 4:30 pm Role type:&nbsp;Onsite (Minneapolis, MN) Open to National Search:&nbsp;No (Local candidates preferred due to short contract length, but not strictly mandatory) Looking for (Skills): Entry-level manufacturing engineer to support the document change system (Windchill) and collaborate with engineers/operators in a medical device cleanroom environment. Must have Skills:
<ul>
<li>Bachelor’s degree in Engineering (any discipline except Civil preferred)</li>
<li>Strong collaboration and communication skills</li>
<li>Ability to learn quickly and work independently</li>
<li>Comfortable working 15–20% of the time in a cleanroom environment (ISO 8, PPE required)</li>
</ul>
Good to have skills:
<ul>
<li>Internship or co-op experience in engineering/manufacturing</li>
<li>Familiarity with document control/change management systems (e.g., Windchill)</li>
<li>Exposure to medical device manufacturing or regulated environments</li>
</ul>
Day-to-day activity:
<ul>
<li>Facilitate and push document/engineering changes through Windchill</li>
<li>Work closely with \~10 frontline engineers and operators</li>
<li>Spend 15–20% time on the cleanroom floor (with PPE)</li>
<li>Support the engineering team with change implementations and documentation</li>
<li>Primarily office-based work with flexibility in schedule (Mon–Fri preferred, Mon–Thurs 4x10 optional)</li>
</ul>
Education: Bachelor’s degree in Engineering (Mechanical, Biomedical, Chemical, Electrical, or related). Civil is not preferred. Experience:
<ul>
<li>0–1 year of relevant experience (recent graduates ideal)</li>
<li>Internship/co-op experience acceptable</li>
<li>Master’s degree candidates are considered overqualified (not preferred)</li>
</ul>
Top skills:
<ul>
<li>Collaboration with engineering/manufacturing teams</li>
<li>Communication (ability to take in and act on information clearly)</li>
<li>Fast learner/ability to work independently</li>
</ul>

Manufacturing Engineer

<h3>Job Description</h3>
About Expanding Innovations
 
At Expanding Innovations, Inc. (EI), we’re redefining what’s possible in spinal fusion. As a fast-growing leader in non-screw-based expandable cage technologies, we’re committed to solving the most complex clinical challenges faced by today’s spine surgeons—ultimately improving patient outcomes through innovation.
 
We’re looking for a driven and experienced R&amp;D Engineer to join our collaborative, fast-paced team and help shape the future of spinal device technology.

 
Position Overview
 
This on-site role is ideal for an engineer who thrives on innovation, cross-functional collaboration, and seeing ideas through from concept to commercialization. You’ll lead one or more product development projects while contributing to a broader portfolio of initiatives across the R&amp;D team.

 
Key Responsibilities
 
Project Leadership
<ul>
<li>Lead one or more product development projects from concept through launch.</li>
<li>Collaborate with cross-functional teams (Product Management, Regulatory, Quality, Manufacturing) to meet project milestones on time and within budget.</li>
<li>Maintain clear project plans and Design History Files (DHF) in compliance with FDA and ISO 13485 standards.</li>
</ul>
 
Design &amp; Development
<ul>
<li>Drive the technical design process, including prototyping, testing, and validation.</li>
<li>Apply engineering principles to optimize product performance, usability, and manufacturability.</li>
<li>Conduct geometric tolerancing analysis and design optimization to enhance the end-user experience.</li>
<li>Participate in and lead product testing (feasibility, ASTM, validation, etc.).</li>
</ul>
 
Risk &amp; Compliance
<ul>
<li>Develop and manage risk documentation (DFMEA, PFMEA, UFMEA) in collaboration with the team.</li>
<li>Ensure adherence to design controls and regulatory requirements throughout the development lifecycle.</li>
</ul>
 
Innovation &amp; IP
<ul>
<li>Contribute to a culture of innovation by generating new ideas, patents, and intellectual property.</li>
<li>Stay current on industry trends, competitive technologies, and emerging materials.</li>
</ul>
 

Qualifications
 
Required:
<ul>
<li>Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field (Master’s or Ph.D. preferred).</li>
<li>5+ years of mechanical design experience in the medical device industry.</li>
<li>Proven track record of leading complex product development projects.</li>
<li>Deep understanding of spinal anatomy, biomechanics, and surgical techniques.</li>
<li>Proficiency in CAD (e.g., SolidWorks), FEA, and other engineering tools.</li>
<li>Strong knowledge of FDA regulations, ISO 13485, and ASTM testing standards.</li>
<li>Excellent communication skills—able to convey complex technical concepts to diverse audiences.</li>
<li>Strong interpersonal skills and a collaborative mindset.</li>
<li>Authorized to work in the U.S. (Visa sponsorship is not available for this role).</li>
</ul>
 
Preferred:
<ul>
<li>A strong preference for work experience in the spine surgical device space, most notably interbody fusion procedures.</li>
<li>Experience with expandable interbody fusion devices.</li>
<li>Expertise in GD&amp;T, 1D tolerance analysis, and 3D modeling/analysis.</li>
<li>Familiarity with sterile packaging and cleanroom manufacturing.</li>
<li>Knowledge of cost-of-goods (COG) optimization through design for manufacturability.</li>
<li>Hands-on experience with manufacturing methods such as machining, injection molding, sheet metal forming, and thermoforming.</li>
</ul>
 
Salary Range: Expanding Innovations, Inc. (EI) complies with all state and federal wage and hour laws.&nbsp;Exact compensation may vary&nbsp;based on candidate’s qualifications, experience, and exact location. $110,000 to $145,000 Full-Time Annual Salary, with annual bonus opportunities and stock incentives.&nbsp;&nbsp;
 
Why Join Us?
<ul>
<li>Be part of a mission-driven team transforming spinal surgery.</li>
<li>Work on cutting-edge technologies with real clinical impact.</li>
<li>Grow your career in a dynamic, innovation-focused environment.</li>
</ul>

Medical Device Product Development Engineer - Spine

<h3>Job Description</h3>
Company Description:
AtaCor Medical is committed to advancing the standard of care in cardiac rhythm management. This mission drives our innovative approach and guides our work to help physicians restore rhythm and preserve life.
 
Position Summary:
This position supports the design and development of new products and product improvements in the extravascular cardiac rhythm management space. Responsibilities will include creation and evaluation of design requirements, development and execution of design verification test methods/protocols/reports, supplier interface and multi-disciplinary project team participation. This position is a full-time, on-site role located at our San Clemente, CA office.&nbsp;
 
Essential Functions:
<ul>
<li>Provides engineering support for design and development of new products and product changes</li>
<li>Use computer-assisted design software (i.e., SolidWorks) to perform engineering and design tasks</li>
<li>Develops and tests prototypes based on design specifications, defines processes to properly manufacture and assemble the product, and optimizes the manufacturing process</li>
<li>Analyzes test data to determine if designs meet functional and performance requirements and document findings in test reports</li>
<li>Conduct engineering inspections of returned product from clinical studies to support complaint and CAPA investigations</li>
<li>Support updates and improvements to QMS procedures</li>
<li>Evaluate the impact of external standard changes on products and their Design History Files (DHFs)</li>
<li>Leverage knowledge of Risk Management, Regulations, and Procedures to ensure continued product compliance</li>
<li>Provides design verification test reports, drawings, and other requirements to Regulatory Affairs necessary for preparing regulatory notifications and submissions such as 510(k)s and PMAs for domestic and international approvals as required</li>
<li>Determines realistic start and finish dates for action items imperative to project completion on the project schedule and submits to the project team leader. Provides updates to project schedule as required</li>
<li>Identify areas for improvement in lab tooling and technical processes across all project phases and recommend changes to the appropriate management.</li>
<li>Supports management of Engineering Lab and provides technical training for appropriate Lab personnel</li>
<li>Reviews appropriate technical literature for the necessary background on specific assignments</li>
<li>All activities must be performed in compliance with the Quality System</li>
<li>Performs duties in compliance with environmental, health, and safety-related site rules, policies, or government regulations</li>
</ul>
 
Essential Qualifications:
<ul>
<li>Education:&nbsp;BS in Biomedical Engineering, Mechanical Engineering, or equivalent combination of education and experience.</li>
<li>Experience:&nbsp;0-3 years industry experience, preferably in medical device design environment.</li>
<li>Working knowledge of light machine shop practice and operation; ability to use shop tools such as drill press, drills, heat sealer, and pull test equipment.</li>
<li>Working knowledge of current CAD tools</li>
<li>Experience in the use of analytical tools and methods including statistics, DOE, and computer analysis packages.</li>
<li>Excellent teamwork and interpersonal skills.</li>
<li>Travel: Up to 15-25%</li>
</ul>
 
Desirable Skills:
<ul>
<li>Experience with SolidWorks</li>
<li>Experience working within an ISO or FDA type design control environment.</li>
<li>Experience working with a contract engineering or manufacturing firm.</li>
<li>Cardiac pacing/defibrillation, implantable, or surgical medical device experience</li>
</ul>

Research And Development Engineer

<h3>Job Description</h3>
HCLTech is looking for a highly talented and self- motivated Validation/Manufacturing Engineer- CNC to join it in advancing the technological world through innovation and creativity.
 
Job Title: Validation/Manufacturing Engineer- CNC
Job ID: 1631955BR
Position Type: Full-time with HCLTech
Location: Warsaw, IN
 
Role/Responsibilities 
 
<ul>
<li>Role: Validate CNC equipment and related processes used to manufacture medical devices.</li>
<li>Focus: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment.</li>
<li>Aim: Ensure robust, reproducible manufacturing processes and maintain inspection-ready documentation.</li>
<li>Develop and execute validation activities for CNC machines (e.g., mills, lathes, multi-axis CNCs) and associated tooling/work holding.</li>
<li>Create and maintain validation documentation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports.</li>
<li>Lead Master Validation Plan, risk assessments (FMEA), and ensure alignment with regulatory requirements (ISO 13485, GMP, 21 CFR Part 820).</li>
<li>Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Equipment Engineering to qualify new machines and implement change controls.</li>
<li>Design, execute, and document calibration, metrology, and gauge R&amp;R activities; ensure traceability of measurement equipment.</li>
<li>Analyze process data (statistical methods, capability studies like Cp/Cpk, Gage R&amp;R) to demonstrate repeatability, accuracy, and process control.</li>
<li>Generate, review, and approve validation reports; ensure closure of deviations, CAPAs, and non-conformances.</li>
<li>Support supplier qualification and acceptance tests for CNC-related components and tooling.</li>
<li>Provide training and knowledge transfer to operators and maintenance staff on validated CNC processes.</li>
<li>Ensure compliance with documentation control, record retention, and audit readiness; participate in internal/external audits.</li>
<li>Maintain equipment lifecycle documentation (maintenance plans, calibration schedules, firmware/software updates) and ensure alignment with change management processes.</li>
<li>Support manufacturing investigations and root-cause analyses related to CNC processes and equipment performance.</li>
<li>Education: Bachelor’s degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline.</li>
<li>Experience: 3–7 years in CNC manufacturing and equipment validation in a regulated environment (MedTech, pharma, or healthcare devices).</li>
<li>Regulatory &amp; Standards: Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820; familiarity with risk management (ISO 14971) and validation concepts (IQ/OQ/PQ).</li>
<li>Proficiency in developing and executing IQ/OQ/PQ protocols.</li>
<li>Experience with metrology, calibration, and measurement system analysis.</li>
<li>Knowledge of CNC machines, CAM software, and basic CNC programming concepts.</li>
<li>Statistical tools experience (Minitab, JMP, or similar) for process capability studies.</li>
<li>Document control and eQMS systems experience (e.g., MasterControl, ETQ, etc.).</li>
<li>Communication: Strong written and verbal communication; ability to write clear validation documentation and present findings to cross-functional teams.</li>
</ul>
 
Pay and Benefits
 
Pay Range Minimum: $ 32.70per hour
Pay Range Maximum: $43 per hour
 
HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to <a href="mailto:secure@hcltech.com" target="_blank">secure@hcltech.com</a> for investigation.
 
Compensation and Benefits
A candidate’s pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death &amp; dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.
 
How You’ll Grow
 
At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.

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