Engineer IV/Complaint Analysts
Takeda
August 14, 2026
On-site
Lexington, MA
$103,500 - $162,690 USD yearly
Operations
Engineer IV, Complaint Analysts
Responsibilities:
- Ensure timely complaint handling and investigations of customer-reported issues for medical devices and combination products.
- Support device technical team with design control deliverables for medical device regulations.
- Develop user/product/system requirements and conduct risk management evaluations.
- Receive, log, triage, and manage customer complaints and returned devices/combination products per procedures and regulatory timelines.
- Perform laboratory evaluation of returned product with appropriate biosafety/contamination controls; execute root cause analysis using structured tools and data trending.
- Document end-to-end complaint activities in the eQMS (investigation results, rationale, conclusions).
- Determine complaint outcomes and support reportability assessments/escalations.
- Initiate/support CAPA and nonconformance records; containment and effectiveness checks; link to investigations.
- Collect and interpret evidence (manufacturing history, risk assessments, nonconformance/stability/compatibility data as applicable).
- Lead technical workstreams; act as technical SME and liaise with external partners.
- Perform design/test activities; develop statistically sound design verification protocols and support design verification.
Qualifications/Skills (required/preferred):
- Associate degree + 4+ years relevant experience, or Bachelor’s in Engineering/Chemistry/Biology/related + 2+ years; regulated lab/quality experience preferred.
- Technical writing for clear, defensible investigation narratives in eQMS.
- Strong collaboration, prioritization, communication; ability to work independently with supervisor support.
- Advanced project management; in-depth risk management knowledge.
- Experience in mechanical/electrical engineering; design verification; prototype testing; mathematical modeling; CAD tools; Quality Management Systems.
Role considerations:
- Controlled manufacturing environment PPE/gowning; cold/wet environment; multiple shifts/weekends as needed; chemical exposure with respiratory protection as required.
Compensation/benefits (as stated):
- Base salary range (Lexington, MA): $103,500–$162,690. Potential incentives; medical/dental/vision, 401(k) match, disability/life insurance, tuition reimbursement, paid volunteer time, holidays, well-being benefits; sick time up to 80 hrs/year; vacation up to 120 hrs for new hires.
Responsibilities:
- Ensure timely complaint handling and investigations of customer-reported issues for medical devices and combination products.
- Support device technical team with design control deliverables for medical device regulations.
- Develop user/product/system requirements and conduct risk management evaluations.
- Receive, log, triage, and manage customer complaints and returned devices/combination products per procedures and regulatory timelines.
- Perform laboratory evaluation of returned product with appropriate biosafety/contamination controls; execute root cause analysis using structured tools and data trending.
- Document end-to-end complaint activities in the eQMS (investigation results, rationale, conclusions).
- Determine complaint outcomes and support reportability assessments/escalations.
- Initiate/support CAPA and nonconformance records; containment and effectiveness checks; link to investigations.
- Collect and interpret evidence (manufacturing history, risk assessments, nonconformance/stability/compatibility data as applicable).
- Lead technical workstreams; act as technical SME and liaise with external partners.
- Perform design/test activities; develop statistically sound design verification protocols and support design verification.
Qualifications/Skills (required/preferred):
- Associate degree + 4+ years relevant experience, or Bachelor’s in Engineering/Chemistry/Biology/related + 2+ years; regulated lab/quality experience preferred.
- Technical writing for clear, defensible investigation narratives in eQMS.
- Strong collaboration, prioritization, communication; ability to work independently with supervisor support.
- Advanced project management; in-depth risk management knowledge.
- Experience in mechanical/electrical engineering; design verification; prototype testing; mathematical modeling; CAD tools; Quality Management Systems.
Role considerations:
- Controlled manufacturing environment PPE/gowning; cold/wet environment; multiple shifts/weekends as needed; chemical exposure with respiratory protection as required.
Compensation/benefits (as stated):
- Base salary range (Lexington, MA): $103,500–$162,690. Potential incentives; medical/dental/vision, 401(k) match, disability/life insurance, tuition reimbursement, paid volunteer time, holidays, well-being benefits; sick time up to 80 hrs/year; vacation up to 120 hrs for new hires.