Technical Source Looking for Design Assurance Engineer at Holly Springs, NC Full Time

Technical Source is currently in search of a Design Assurance Engineer for our medical device design/manufacturing client in the RTP area. You will be working with an R&D team that designs and develops state-of-the-art medical device technology, ensuring the accuracy and quality of design control requirements. The qualified candidate will have experience in new product development and regulatory submissions for medical devices.

Responsibilities of the Design Assurance Engineer include:

• Provide support and oversight of design development, review, testing and verification, and changes for medical device products
• Maintain and ensure compliance of design history files and approve design verification test plans and protocols
• Lead regulatory documentation efforts for product clearances and regulatory submissions

Qualifications of the Design Assurance Engineer include:

• 2+ years of experience in medical device product development
• Experience with design history files for medical device products
• Bachelor’s degree in engineering or a related field

Compensation for the Design Assurance Engineer includes:

• $80,000 – $110,000/yr based on breadth of experience and fit
• Medical, dental and vision benefits
• No Corp to Corp or Visa sponsorships at this time

Keywords: design history files, DHF, sustaining engineering, design control, medical device, design, documentation, engineering, manufacturing, biomedical, FDA, quality engineering, research and development, R&D, new product development, sustaining engineering, risk management, design review, CAPA, ISO 13485, 21 CFR 820, 510(k), 510K, EU CE, project engineer, validation and verification, V&V, document control, design assurance, design quality, design verification, design engineer, quality engineer

Job Type: Full-time

Pay: $80,000.00 – $110,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor’s (Preferred)

Experience:

• medical device product development: 1 year (Preferred)

Work Location: Multiple Locations