No C2C / Only W2 / No Sponsership Seeking an experienced Senior Design Quality Engineer to support development of complex robotic and electromechanical Class III medical systems. This role leads ...
No C2C / Only W2 / No Sponsership Seeking an experienced Senior Design Quality Engineer to support development of complex robotic and electromechanical Class III medical systems. This role leads ...
Drive design control execution for multiple concurrent medical device NPD programs, ensuring high-quality, audit-ready technical documentation. * Lead and support the creation, review, and approval ...
Drive design control execution for multiple concurrent medical device NPD programs, ensuring high-quality, audit-ready technical documentation. * Lead and support the creation, review, and approval ...
Design medical device mechanical components and packaging. * Perform Design Failure Mode and Effects Analysis (DFMEA) and User Failure Mode and Effects Analysis (UFMEA) * Lead design verification and ...
Design medical device mechanical components and packaging. * Perform Design Failure Mode and Effects Analysis (DFMEA) and User Failure Mode and Effects Analysis (UFMEA) * Lead design verification and ...
Senior Medical Device Compliance Engineer
Needham, MA · On-site
$113K - $156K/yr
About Us SharkNinja is a global product design and technology company, with a diversified portfolio ... Senior Medical Device Compliance Engineer Needham, MA, United States The Senior Medical Device ...
Senior Medical Device Compliance Engineer
Needham, MA · On-site
$113K - $156K/yr
About Us SharkNinja is a global product design and technology company, with a diversified portfolio ... Senior Medical Device Compliance Engineer Needham, MA, United States The Senior Medical Device ...
Sr. Engineer, Device Development
Bedford, MA · On-site
$140K - $155K/yr
Design medical device mechanical components and packaging. * Perform Design Failure Mode and Effects Analysis (DFMEA) and User Failure Mode and Effects Analysis (UFMEA) * Lead design verification and ...
Sr. Engineer, Device Development
Bedford, MA · On-site
$140K - $155K/yr
Design medical device mechanical components and packaging. * Perform Design Failure Mode and Effects Analysis (DFMEA) and User Failure Mode and Effects Analysis (UFMEA) * Lead design verification and ...
Support compliance with medical device design control and product development processes, including documentation and change management activities. * Ensure project activities, meeting outcomes ...
Support compliance with medical device design control and product development processes, including documentation and change management activities. * Ensure project activities, meeting outcomes ...
Support compliance with medical device design control and product development processes, including documentation and change management activities. * Ensure project activities, meeting outcomes ...
Support compliance with medical device design control and product development processes, including documentation and change management activities. * Ensure project activities, meeting outcomes ...
Staff Design Quality Engineer
Burlington, MA · On-site +1
The Staff Design Quality Engineer is responsible for supporting new hardware and software medical device product development, sustaining product line activities, and hardware customer quality ...
Staff Design Quality Engineer
Burlington, MA · On-site +1
The Staff Design Quality Engineer is responsible for supporting new hardware and software medical device product development, sustaining product line activities, and hardware customer quality ...
Senior Project Manager (MedTech/Medical/NPD)
Andover, MA · On-site
$98K - $124K/yr
Medical device design controls (21 CFR 820.30) * Soft Skills: Strong communication, problem-solving, adaptability Required Qualifications * 10+ years in program/project management * Experience in ...
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Senior Project Manager (MedTech/Medical/NPD)
Andover, MA · On-site
$98K - $124K/yr
Medical device design controls (21 CFR 820.30) * Soft Skills: Strong communication, problem-solving, adaptability Required Qualifications * 10+ years in program/project management * Experience in ...
Principal or Senior Electrical Engineer
Burlington, MA · On-site
$151K - $185K/yr
Job Overview We are seeking a highly skilled Principal or Senior Electrical Engineer with 8-10+ years of experience in medical device design and development . This role is hands-on and will focus on ...
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Principal or Senior Electrical Engineer
Burlington, MA · On-site
$151K - $185K/yr
Job Overview We are seeking a highly skilled Principal or Senior Electrical Engineer with 8-10+ years of experience in medical device design and development . This role is hands-on and will focus on ...
Collaborate in multifunctional teams to develop strategies that challenge the medical device design ... and performance and create objective evidence for quality and safety compliance. * Participate in ...
Collaborate in multifunctional teams to develop strategies that challenge the medical device design ... and performance and create objective evidence for quality and safety compliance. * Participate in ...
Collaborate in multifunctional teams to develop strategies that challenge the medical device design ... and performance and create objective evidence for quality and safety compliance. * Participate in ...
Collaborate in multifunctional teams to develop strategies that challenge the medical device design ... and performance and create objective evidence for quality and safety compliance. * Participate in ...
Prior experience in medical device or other highly regulated industry * Experienced with FDA ... Design Control requirements, ISO 13485 Medical Device Quality management System, ISO 14971:2019 ...
Prior experience in medical device or other highly regulated industry * Experienced with FDA ... Design Control requirements, ISO 13485 Medical Device Quality management System, ISO 14971:2019 ...
Sr. Design Assurance Engineer - Risk Management
Marlborough, MA · On-site
$97K - $152K/yr
Prior experience in medical device or other highly regulated industry * Experienced with FDA ... Design Control requirements, ISO 13485 Medical Device Quality management System, ISO 14971:2019 ...
Sr. Design Assurance Engineer - Risk Management
Marlborough, MA · On-site
$97K - $152K/yr
Prior experience in medical device or other highly regulated industry * Experienced with FDA ... Design Control requirements, ISO 13485 Medical Device Quality management System, ISO 14971:2019 ...
Sr. Human Factors and Usability Engineer Location- Waltham, MA Duration: Long Term Candidate must be from medical device Subject matter expertise and experience with medical device design and ...
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Sr. Human Factors and Usability Engineer Location- Waltham, MA Duration: Long Term Candidate must be from medical device Subject matter expertise and experience with medical device design and ...
Responsible for coordinating Design Verification (DV) activities between client stakeholders and ... medical device verification projects. Acts as the primary point of contact for project tracking ...
Responsible for coordinating Design Verification (DV) activities between client stakeholders and ... medical device verification projects. Acts as the primary point of contact for project tracking ...
Quality Engineer (Contract)
Bedford, MA · On-site
$45 - $55/hr
Experience in medical device design assurance * Experience in design verification and transfer to manufacturing activities * Understanding of medical device design controls and risk management ...
Quality Engineer (Contract)
Bedford, MA · On-site
$45 - $55/hr
Experience in medical device design assurance * Experience in design verification and transfer to manufacturing activities * Understanding of medical device design controls and risk management ...
Senior Mechanical Engineer - Medical Device
Somerville, MA · On-site
$80K - $100K/yr
Somerville, MA Senior Mechanical Engineer - Medical Device Overview: Micro-Leads is a fast-paced ... The individual will design electrodes for stimulation and nerve recordings. In addition, the ...
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Senior Mechanical Engineer - Medical Device
Somerville, MA · On-site
$80K - $100K/yr
Somerville, MA Senior Mechanical Engineer - Medical Device Overview: Micro-Leads is a fast-paced ... The individual will design electrodes for stimulation and nerve recordings. In addition, the ...
Senior Mechanical Engineer - Medical Device
Somerville, MA · On-site
$80K - $100K/yr
Somerville, MA Senior Mechanical Engineer - Medical Device Overview: Micro-Leads is a fast-paced ... The individual will design electrodes for stimulation and nerve recordings. In addition, the ...
Quick apply
Senior Mechanical Engineer - Medical Device
Somerville, MA · On-site
$80K - $100K/yr
Somerville, MA Senior Mechanical Engineer - Medical Device Overview: Micro-Leads is a fast-paced ... The individual will design electrodes for stimulation and nerve recordings. In addition, the ...
Program Manager - Medical Device
$120K - $140K/yr
Develop and maintain compliant design/process documentation; oversee test and measurement fixture ... Knowledge of GMP principles and their application in medical device manufacturing, including ...
Program Manager - Medical Device
$120K - $140K/yr
Develop and maintain compliant design/process documentation; oversee test and measurement fixture ... Knowledge of GMP principles and their application in medical device manufacturing, including ...
Medical Device Design information
See Boston, MA salary details
$23.24 - $30.67
5% of jobs
$37.83 is the 25th percentile. Wages below this are outliers.
$30.67 - $38.10
21% of jobs
$38.10 - $45.54
21% of jobs
The median wage is $48.43 / hr.
$45.54 - $52.97
9% of jobs
$52.97 - $60.40
16% of jobs
$62.26 is the 75th percentile. Wages above this are outliers.
$60.40 - $67.83
11% of jobs
$67.83 - $75.26
6% of jobs
$75.26 - $82.69
7% of jobs
$82.69 - $90.12
2% of jobs
$90.12 - $97.55
1% of jobs
$97.55 - $104.98
0% of jobs
$23
$54
$104
How much do medical device design jobs pay per hour?
What is a medical device design?
A Medical Device Design job involves creating, developing, and improving medical devices to ensure they are safe, effective, and user-friendly. Professionals in this field work with engineers, regulatory specialists, and healthcare professionals to meet industry standards and patient needs. They use computer-aided design (CAD) software, prototyping, and testing methodologies to refine devices before production. The role requires knowledge of biomechanics, materials science, and regulatory guidelines such as FDA and ISO standards.
What are some typical challenges faced in a medical device design role?
Medical Device Design professionals often encounter challenges such as balancing innovative design with stringent regulatory requirements and ensuring devices are both effective and safe for patient use. Navigating complex approval processes, collaborating with clinicians for feedback, and keeping up with rapidly evolving technologies can also be demanding. However, these challenges make the role dynamic and rewarding, as designers play a direct role in improving patient outcomes. Team-based problem solving and ongoing learning are key parts of the job, and successfully overcoming challenges can lead to career growth and leadership opportunities within the medical device industry.
What are the key skills and qualifications needed to thrive in medical device design, and why are they important?
Success in Medical Device Design requires a solid understanding of biomedical engineering, materials science, and human anatomy, often supported by a relevant engineering degree and experience in product development. Familiarity with CAD software, rapid prototyping tools, and regulatory standards such as FDA or ISO 13485 certification is common in the field. Strong problem-solving abilities, teamwork, and effective communication help professionals excel in multidisciplinary design teams. These competencies are crucial for creating safe, innovative medical devices that meet strict quality and regulatory requirements.
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Job description
Seeking an experienced Senior Design Quality Engineer to support development of complex robotic and electromechanical Class III medical systems. This role leads Design Controls, risk management, and V&V quality oversight to ensure regulatory compliance and robust product realization across the lifecycle.
Responsibilities:
- Serve as Quality representative and Design Controls lead on cross-functional teams.
- Ensure compliance with FDA QSR (21 CFR 820.30), ISO 13485, MDR/MDD, and global regulations.
- Lead risk management per ISO 14971, including system-level risk analysis, FMEA/SWFMEA, and residual risk evaluation.
- Maintain end-to-end traceability between design inputs/outputs, risk controls, and verification & validation (V&V).
- Review/approve V&V protocols and reports; support tolerance, worst-case, and margin analyses.
- Support IEC 60601-1, IEC 60601-1-2, IEC 80601-2-77 electrical safety/EMC compliance.
- Collaborate on HW/SW integration and ensure compliance with IEC 62304/82304.
- Support supplier qualification, design transfer, and DHF completeness.
- Contribute to IDE, De Novo, PMA submissions.
- Lead CAPA, NCMR, complaint investigations, and root cause analysis.
Qualifications:
- Bachelor's degree in Engineering, Biomedical Engineering, or Life Sciences.
- 7-10 years' experience in Design Quality within medical devices (Class III preferred).
- Strong knowledge of Design Controls, QSR, ISO 13485, ISO 14971.
- Experience with Minitab or statistical analysis tools.
- Familiarity with ESD controls, electrical components handling.
- Strong technical writing, communication, and time management skills.
About CONFLUX SYSTEMS
Sourced by ZipRecruiter
Company size
11 - 50 Employees
Headquarters location
Alpharetta, GA, US
Year founded
2007