Senior Design Assurance Engineer

Nextern•Maple Grove, MN

1d•$29 - $34

About The Position

The Senior Design Assurance Engineer is responsible for design quality input and deliverables for new product development programs throughout the product lifecycle. Design Assurance Engineers 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.

Requirements

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..).
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).

Nice To Haves

Familiarity with statistical software, such as Minitab, preferred.

Responsibilities

Project core team member accountable for product development deliverables including, but not limited to:
Design Controls (plan, inputs/outputs, verification, design review, etc..) per 21 CFR820.30
Risk Management (Plan/Report, Hazards Analysis, FMEA/Risk Assessment) per ISO 14971
Equipment and Material Qualification
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