$120,000–$140,000 Per Year
Biology, Change Control, Code of Federal Regulations, Congestive Heart Failure, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Document Change Management, Document Management, Documentation, Embedded Systems, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), Hazard Analysis, ISO (International Organization for Standardization), Maintain Compliance, Manufacturing Operations, Medical Equipment, Process Validation, Product Design, Product Development, Product Lifecycle, Production Specifications, Quality Engineering, Quality Metrics, Regulatory Compliance, Regulatory Requirements, Risk Analysis, Risk Management, Standards Development, Statistics, Team Player, Technical/Engineering Design, Validation Testing
The Senior Design Quality Engineer is responsible for ensuring quality is embedded throughout the product development lifecycle, from concept through commercialization and post-market support. This role partners closely with cross-functional teams to ensure products meet regulatory requirements, internal quality standards, and customer expectations.
Client Details
My client is driven by a mission rooted in innovation, transparency, and patient benefit, the company emphasizes excellence in design, adherence to global regulatory standards, and the development of a collaborative, talent‑focused workplace. With continued investment, substantial venture backing, and ongoing expansion of its technology platform, the organization remains at the forefront of advancing next‑generation treatment solutions for chronic heart failure
Description
The key responsibilities of the Senior Design Quality Engineer are:
- Serve as the Quality representative on cross-functional product development teams.
- Ensure compliance with design control procedures (e.g., FDA 21 CFR Part 820, ISO 13485).
- Review and approve design documentation, including design inputs, outputs, verification, validation, and design transfer activities.
- Support the development and maintenance of Design History Files.
- Lead and support risk management activities in accordance with ISO 13485:2016, 21 CFR Part 820 and MDSAP
- Facilitate risk assessments including FMEA/FMECA, hazard analyses, and risk/benefit evaluations.
- Ensure risk controls are effectively implemented, verified, and documented
- Collaborate with Manufacturing and Operations to ensure smooth design transfer and process readiness.
- Review production specifications, process validations, and inspection criteria.
- Support process validation activities and ensure quality requirements are maintained in production.
If interested, please apply using the link below. Qualified applicants will be contacted 24-48 hours upon submittal.
Profile
The successful Senior Design Quality Engineer will have:
- Bachelor's degree in Engineering, Life Sciences, or a related technical field (Master's preferred).
- 5+ years of experience in Design Quality, Quality Engineering, or related roles within the medical device industry.
- Strong knowledge of design controls and product development processes.
- Deep understanding of ISO 13485 requirements.
- Experience with risk management standards (ISO 14971).
- Familiarity with verification & validation methodologies and statistical analysis tools.
- Experience with CAPA systems, change control, and document management systems.
Job Offer
My client can offer the following:
- Full Coverage Medical Benefits - Employee + family contribution is 100%
- Paid Vacation, floating holidays, and sick time.
- Paid Holidays
- 401k Match (up to 6%)
- Annual bonus eligibility
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.