Acton, Massachusetts, United States · Hybrid
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Skills: Systems Engineering, Risk Management, Root Cause Analysis, Requirements Management, Medical Device Regulations
Devens, Massachusetts, United States · On-site
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Dedham, Massachusetts, United States · On-site
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Taunton, Massachusetts, United States · On-site
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Taunton, Massachusetts, United States · On-site
$150k–$160k/yr
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Toronto, Ontario, Canada · Remote OK
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San Francisco, California, United States · Hybrid
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Cambridge, Massachusetts, United States · On-site
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Boston, Massachusetts, United States · On-site
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Boston, Massachusetts, United States · Hybrid
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Chelmsford, Massachusetts, United States · On-site
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Bedford, Massachusetts, United States · Hybrid
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Stoneham, Massachusetts, United States · On-site
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Acton, Massachusetts, United States • Hybrid
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Lead the definition, integration, and characterization of innovative medical product content while driving root cause investigations and risk analysis. Ensure all design changes and system verifications adhere to stringent medical device regulations and quality standards.
Requires a Bachelor's degree in Engineering or a related field with at least 6 years of systems engineering experience in product development. Must have 4+ years of experience in the medical device industry and proficiency with requirements management software like Jama or Polarion.
Job Summary
The Senior Systems Lifecycle Engineer is a technical expert who leads and contributes to the definition, integration, and characterization of innovative product content. The successful candidate will drive system engineering activities within Life Cycle Engineering, including root cause investigations and in-depth analysis of product architecture, requirements and risks, providing effective solutions that adhere to stringent medical device regulations and quality standards. This role requires exceptional analytical, problem-solving, and communication skills to work effectively with multi-disciplinary teams.Key Responsibilities:
Systems Design and Development
Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables.
Serves as a system technical expert for design changes to subsystems by driving requirement refinement, performing risk reviews, implementing risk mitigations, and developing system verification plans to verify the design change.
Perform functional analysis, timeline analysis, and detailed trade-off studies to drive design improvements and cost-reduction to existing subsystems.
Troubleshoot system-level issues, perform root cause analysis, and implement effective solutions throughout the development process.
Risk Management and Compliance
Lead risk management activities, including hazard identification and Failure Modes and Effects Analysis (FMEA), throughout the product lifecycle in accordance with ISO 14971.
Ensure that all design and development activities comply with regulatory requirements, including FDA Quality System Regulation (QSR) 21 CFR Part 820, ISO 13485, and IEC 60601.
Work closely with regulatory affairs and quality assurance teams to prepare and maintain the Design History File (DHF) and other technical documentation for regulatory submissions.
Support external audits conducted by regulatory bodies such as the FDA or Notified Bodies.
Verification, Validation, and Testing
Develop, author, and execute comprehensive test plans, protocols, and reports for system integration, verification, and validation.
Coordinate testing to ensure compliance with all applicable safety and performance standards.
Analyze test data, interpret results, and formally document conclusions to verify that design outputs meet design inputs.
Product Support and Sustaining Engineering
Provide technical support and expertise to cross-functional teams for post-market surveillance and continuous improvement activities.
Analyze and address customer complaints and field issues through risk assessments and technical investigations.
Manage device and manufacturing process changes, including documentation updates and risk file maintenance.
Leadership and Mentorship
Guides and offers expertise with peers, providing guidance on systems engineering processes and tools.
Effectively communicate technical risks and proposed solutions to program level stakeholders.
Qualifications:
Education
Bachelor of Science required (preferred field of study in: Engineering, Biomedical, Electrical, Mechanical, Systems)
M.S. in engineering, related field or engineering management considered a plus.
Experience
4+ years of experience working in the medical device industry/ highly regulated product development industry.
6+ years of experience working directly in a Systems Engineering discipline within product development.
Technical Skills
Proficiency in system-level design, requirements management, and architectural development.
Solid understanding of medical device regulations (FDA QSR, ISO 13485) and risk management (ISO 14971).
Demonstrated success in managing programs/projects involving multiple disciplines from development through commercialization
Experience with requirements management software (e.g., Jama, Polarion, Doors) is required.
Experience with systems verification/validation, including test method development.
Soft Skills
Strong analytical and problem-solving abilities.
Excellent written and verbal communication skills.
Demonstrated ability to collaborate effectively with cross-functional and global teams.
Strong organizational skills and attention to detail, particularly for regulatory documentation
Creative out-of-the box thinker who can devise new approaches and processes that meet regulatory needs but adaptive to address business and market needs.
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office). #LI-Hybrid
Additional Information:
Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $102,400.00 - $153,550.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Omnipod products are offered in 25 countries around the globe. HIRING SCAM ALERT Recently, individuals impersonating Insulet Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that: • Insulet will never interview a candidate over RingCentral, similar messaging apps or social media (i.e. Google Hangouts, WhatsApp, Facebook Messenger, etc.), or via text message. • Insulet will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment. • Insulet will never provide excess money to an applicant and ask the applicant to write a check for repayment. If you have any doubt about a job offer or any other communication purporting to come from Insulet, please reach out to us directly at 978-600-7000. If you receive any type of communication on behalf of Insulet that seems inappropriate or suspicious, please report this activity to: www.iC3.gov or www.stopfraud.gov.
Offices: 100 Nagog Park, Acton, Massachusetts 01720, US · 245 Hammersmith Road, 6th Floor, London, England W6 8DL, GB · 1540 Cornwall Road, Suite 201, Oakville, Ontario L6J 7W5, CA · 9276 Scranton Rd, San Diego, California 92121, US
Based on 6076 listings with disclosed salaries, most engineering jobs in Massachusetts pay between $87k–$205k per year. Individual offers vary with seniority, company size, and specialization.
There are currently 8,880 open engineering positions in Massachusetts listed on Clera. New openings are added daily as companies post roles.
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