About the Role
Key Responsibilities
Reliability Engineering: Develop and conduct reliability assessments (FMEAs, life/failure data analysis, stress tests) to identify potential failure modes and mitigate risks early in design . Plan and execute reliability test campaigns (e.g. accelerated life testing, HALT, environmental stress) and analyze results statistically (DOE, ANOVA, Weibull analysis) to predict product lifetime and guide improvements . Collaborate with R&D/design teams to integrate these findings into product design, ensuring a robust, durable design (adding safety margins or redundancy where needed) . Investigate field or prototype failures (root-cause analysis) and drive corrective actions to improve reliability over the product lifecycle .
Design Control & Documentation: Lead the design control process in compliance with FDA and ISO requirements. Prepare and maintain design planning documents and the Design History File (DHF) – a master record of the design process – capturing design inputs, outputs, reviews, verification/validation protocols, and risk analyses. (FDA explicitly requires the “entire history of your document control process” to be kept in the DHF .) You ensure that design inputs (customer needs, performance requirements, safety/regulatory specs) are translated into verifiable design outputs, and that formal design reviews occur at key milestones. Oversee design changes by documenting revisions and re-running appropriate verification/validation. In practice this means driving all technical documentation (device design/testing reports, manufacturing process controls, change-control records) and owning the DHF so traceability from requirements through verification results is complete .
Risk Management & Verification: Implement and manage risk analyses (per ISO 14971) in parallel with design control. Perform detailed FMEAs or hazard analyses to assess design risks, and maintain traceability between user/functional requirements, identified risks, and mitigations . Ensure that risk control measures are verified or validated. Drive design verification and validation testing (bench, lab or clinical tests, software validation as applicable) to confirm that design outputs meet all inputs and that the final product fulfills its intended use .
Regulatory Compliance: Ensure all design and development activities comply with applicable regulations and standards. This includes FDA’s Quality System Regulation (especially 21 CFR 820.30 – Design Controls) and ISO 13485:2016 requirements for design and development . You document compliance by providing traceable evidence in the DHF and Quality Management System (QMS) records. Collaborate with quality/regulatory teams during audits or submissions, supplying design control documentation (design plans, reviews, verifications, validation reports, risk files) as needed to demonstrate a controlled process. In short, you make sure that both the process (design control procedures) and the product (device performance) meet global regulatory expectations.
Qualifications & Skills
Education & Experience: Bachelor’s degree (minimum) in an engineering discipline (Mechanical, Electrical, Biomedical, Industrial, Materials Science or similar) . Advanced degrees (MS, PhD) are a plus or may offset experience requirements. Typically 2–5+ years of relevant experience in medical device development, reliability engineering or quality engineering is expected . Experience should include hands-on reliability analysis and/or design control in a regulated environment (Class II/III devices preferred).
Professional Certifications: Industry-recognized certifications are highly valued. For example, ASQ’s Certified Reliability Engineer (CRE) credential signifies expertise in “reliability, maintainability, and safety of products” , while ASQ’s Certified Quality Engineer (CQE) covers quality control, statistical methods, and regulatory compliance . Six Sigma Green/Black Belt certification or equivalent demonstrates proficiency in process improvement and statistical tools.
Technical Skills: Strong background in statistical and reliability engineering tools – e.g. Design of Experiments (DOE), Statistical Process Control, regression and ANOVA, Gage R&R – for data analysis . Skilled in conducting and analyzing FMEA/risk assessments and in using reliability prediction/testing software. Hands-on experience with reliability test methods (HALT/HASS, accelerated life testing, environmental testing per ASTM/FDA 21 CFR 820.198) and with design verification/validation testing (performance, safety, software/biocompatibility tests). Proficient with quality systems and document control software (QMS tools, PLM) and familiar with CAD and simulation tools (for tolerance and FEA analysis). Working knowledge of FDA and ISO standards (21 CFR 820.30, 21 CFR 820.198, ISO 13485, ISO 14971, ISO 9001) and GMP/QSR requirements .
Additional Skills: Excellent analytical, problem-solving and project management skills. Strong communication and documentation skills are essential for writing clear procedures, reports and DHF entries. The role often involves leading cross-functional teams (engineering, manufacturing, QA/RA), so interpersonal skills and the ability to manage competing priorities are important . Attention to detail, a proactive attitude, and commitment to continuous improvement round out the profile of a successful candidate in this position.
Requirements
Role Overview: Integrate reliability engineering with formal design control processes to ensure medical devices meet stringent safety, performance, and regulatory requirements. In this role, you apply quantitative reliability analyses (life data analysis, HALT/HASS, etc.) and Failure Mode & Effects Analyses (FMEAs) to design robust products, while managing the regulated design control process per FDA 21 CFR 820.30 and ISO 13485. The goal is a device that consistently meets user needs and specifications; as one source notes, reliability engineering “complements the successful implementation of design control” to achieve products that are durable, safe, and user-friendly .
About the Company
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