The Design Assurance Engineer will work as a member of the Engineering project teams in New Product Development and Sustaining Engineering in the development and maintenance of Design History Files, necessary design control documentation and regulatory compliance for medical devices.
This individual has joint responsibility for the design and development plan with the overall project leader and helps project teams deliver complex medical device projects on time with the highest quality and product safety. They will ensure that design control requirements as defined by all relevant company SOPs are adhered to, and that safety and efficacy are demonstrated. At all times throughout the process, they will identify and mitigate risks. They will also work with regulatory bodies to ensure products meet the necessary standards as well as work with the entire organization on regulatory clearance for new geographical areas, features and product lines.
Key Responsibilities May Include:
- Provide support and oversight for product design activities including: Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes.
- Ensure compilation and maintenance of product Design History Files.
- Partner with R&D engineers and Sustaining Engineering to ensure design reviews are thorough and robust.
- Review and approve Design Verification and Validation test plans, protocols and reports; guide the use of robust statistical techniques.
- Ensure documentation of traceability of requirements through design output and to design verification and/or design validation.
- Drive project teams towards early requirements maturation, early test plan/script development, and design input requirements that are indicative of real-world use case environment and customer needs.
- Participate in cross-functional reviews to analyze, prioritize and disposition design defects (including software anomalies).
- Review intended use validation for non-product software and tools used in the development process.
- Actively participate with design teams on developing product Risk Management Files; ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards.
- Support the CAPA process by performing investigation, root cause analysis and verification of effectiveness checks for design related issues.
- Support internal and external regulatory and customer audits.
- Participate in the improvement of the manufacturing process for existing products as needed.
- Lead regulatory efforts for product clearances both within the US and outside the US.
- Review and approve work instructions, inspection documents, Bills of Material and drawings as needed.
- Bachelor’s Degree in engineering or related field is required.
- 5+ years’ experience in medical in a design/development.
- Knowledge and experience with complex multifunctional systems is required.
- Strong, demonstrated ability to interact closely on technical terms with R&D personnel is required.
- Strong ability to facilitate cross-functional team meetings and the ability to drive project teams towards strong product quality, safety and compliance is required.
- Detail oriented with strong organizational and record keeping skills is required.
- Strong advocate of process and accountability and not afraid to challenge when necessary.
- Strong problem solving and root cause analysis skills is required.
- Strong working knowledge of design controls as required by FDA 21 CFR 820.30 and ISO 13485 product realization is required.
- Strong written and oral communications skills using English language is required; ability to succinctly and clearly describe complex issues in meaningful ways is required.
- Ability to engage different functions in meaningful discussions and maintain enthusiasm for efforts is required.
- Demonstrated ability in being proactive and timely in execution of assigned tasks is required.
- Ability to be flexible and adaptable to changing priorities is required.
- Experience with 510K and EU CE clearances is preferred.
Surround Medical Systems, Inc is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
Primary Work Location: USA Morrisville, NC – onsite
Reports to: Director, Engineering
Authorized to work in the US