Senior Design Assurance Engineer

The Senior Design Assurance Engineer is responsible for design quality input and deliverables for new product development programs throughout the product lifecycle. They will also support sustaining activities for investigational and commercial device manufacturing, such as changes, audits, and post-market surveillance ensuring a continuously accurate and compliant Design History File. All engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.

DUTIES AND RESPONSIBILITIES:

· Project core team member accountable for product development deliverables including, but not limited to:

o Design Controls (plan, inputs/outputs, verification, design review, etc..) per 21 CFR820.30

o Risk Management (Plan/Report, Hazards Analysis, FMEA/Risk Assessment) per ISO 14971

o Equipment and Material Qualification

o Test Method development and validation

· Draft, collaborate, and approve product development deliverables and engineering work orders

· Consult and provide guidance on biocompatibility testing per ISO 10993 or collaborate with outside Contract Research Organization

· Coordinate and execute, as necessary, testing in support of new product development (e.g. DV, pVal, etc..)

· Support the transfer of designs from R&D to manufacturing

· Create and maintain up-to-date product Design History Files (DHF)

· Advise project teams and lead by example in best-practices for Quality and Regulatory compliance

· Proactively identify redundancy and opportunities for efficiency in Quality System requirements

· Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) are appropriately documented and executed with a lens towards design, risk, and regulatory compliance

· Receive, investigate, and document product complaints, interacting with customers as applicable

· Support audits as Subject Matter Expert (SME) for QMS processes and product DHFs

· Drive Product Lifecycle Management (PLM) architecture and changes, as needed

QUALIFICATIONS:

·Bachelor's Degree (BS) in life science discipline or equivalent combination of education and experience.

· 5+ years of experience in medical device development, or 3+ years of experience in a Design Assurance or Quality Engineering role

· Experience working in quality systems as defined in 21 CFR 820 and ISO 13485.

· Development project team member on complex medical device development programs, including systems

· Understanding of ISO 14971 and application of risk management to product development and processes.

· Demonstrated technical expertise and leadership in quality.

· High attention to detail, organization, and accuracy.

· Instinctual capability for creative thinking and proposing novel solutions

· Strong ability to communicate (written and verbally) within and across disciplines and organization structures.

· Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc..).

· Familiarity with statistical software, such as Minitab, preferred.

· Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)

· Intermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook).

Nextern offers excellent benefits to fuel you in building a fulfilling life & career:

• The expected salary range for this position is between $115,000 - $130,000
• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, AND Birthday Holiday!
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Short-Term & Long-Term Disability