Design Assurance Engineer II
Posted on Apr 17, 2019 by TE Connectivity
TE's Medical business unit, part of the Industrial Solutions segment, offers medical device OEMs, a complete product offering, and capability portfolio for minimally invasive, imaging, surgical, diagnostic, and therapeutic devices. With more than 350 design engineers and a global presence in all key medical device hubs, we are a premier partner to the world's leading medical technology companies for their next-generation medical devices. We are experts in all aspects of device design and manufacture, from access & delivery solutions for interventional medicine; to sensors & connectors for surgical applications. Our innovative solutions enable ground breaking medical therapies such as treating heart disease without opening the body, placing microscopic devices into brain arteries and powering robotic surgery.
The Design Assurance Engineer provides input to our design development teams in the design and development of highly complex medical devices. They work to ensure that all Design Development activities are conducted in compliance to customer and regulatory requirements to help ensure successful transfer of the design to manufacturing. They are responsible for accurate, independent evaluation of the Design History File documentation and are responsible to ensure compliance to the Quality System. This individual will report to the Quality Manager at the site with indirect reporting to the corporate function of Regulatory Affairs to ensure design compliance of new developed products.
- Supports audits from external regulatory agencies (FDA, BSI, JPAL) and customers.
- Addresses customer issues and promotes customer satisfaction to deliver on an extraordinary customer experience.
- Acts as the liaison for quality management to oversee the design development of Design History Files (DHF) for new products and ensures regulatory compliance.
- Ensures effective and efficient process controls are implemented and maintained in the early stages of design development (inspection standards, plans, frequencies and test methods).
- Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical engineering techniques, testing procedures and criteria.
- Works closely with product development engineering and the client team to establish the system design specifications and product requirements.
- Works closely with design, development, quality, regulatory, and the client team to establish and document the master verification plan in conformance with the system design specification and sound testing principles.
- Performs and documents all engineering studies and reports to satisfy the master verification plan.
- Plans, coordinates and executes design verification testing to directly support the master verification plan.
- Participates with the engineering team to establish and review the design FMEA.
- Routinely provides design assurance guidance and direction to engineers and/or technicians for the duration of a project assignment.
- Evaluation of new products, assuring the safety and efficacy of the devices.
- Creates design verification and shelf life protocols / reports review.
- Initiates and completes root cause investigations
- Clearly presents information to Regulatory Affairs to minimize Regulatory Agency questions.
- Supports customer complaint analysis and post market surveillance activities.
- Generates and approve change requests associated with new design development projects
- Ensures that quality plans for new design develop products (validation plans, raw/component material specifications, etc.) and risk management files are appropriately established.
- Develops pre-clinical evaluation plans and coordinates the necessary test requirements of new product design.
- Participates and takes an active role the execution of the site's TEOA Program regarding design development projects.
- BS/BA degree with a scientific emphasis required
- Min. 5 years' experience as quality engineer
- Good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
- ASQ Certified Quality Engineer preferred
- Six Sigma Green/Black belt preferred
- Quality experience in component and device manufacturing preferred.
- Excellent written and oral communication skills essential.
What TE Connectivity Offers
We offer a competitive "total rewards" compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive, and meets the needs of our employees.
- Generous 401(k) Plan
- 100% Tuition Reimbursement
- Benefits start on day one
- Charity Donation Matching Program
- Competitive Paid Time Off
- Employee Resource Groups
- Employee Stock Purchase Program
- Healthcare for Associates and Families
- Health and Wellness Incentives
- Life Insurance and Disability Protection
Throughout our Global reach and various Business Units, we take a balanced approach to the benefits we provide. Many benefits are company-paid, while others are available through associate contribution. Specific benefit offerings can vary by location.