Design Controls Engineer
901 Main Campus Drive Raleigh, NC 27606 US
Position Description: Protingent Staffing has an exciting contract opportunity for Design Controls Engineer with our client that is located in Raleigh, NC.
Job Responsibilities: The Design Controls Engineer plays a vital role in developing safe and effective medical devices. As an embedded member of the New Product Development (R&D) team, they support the rapid and efficient development of new products, while ensuring that complete and transparent records of product designs are created and maintained. They work closely with a team of exceptionally talented engineers and design professionals developing highly innovative products for use in the operating room. Their work helps safeguard the integrity of the design and ensures that Design History Files (DHF’s) meet all regulatory requirements. The Design Controls Engineer demonstrates a strong sense of pride in their work output and a real interest in technology, products, and applications.
• Assist the new product development team with compiling and updating of engineering design control documents for Design History Files, including risk analyses, requirements, trace reports, and design verification and validation test documentation.
• Assist the cross functional new product development team with architecting a holistic documentation/tracing structure that is easily maintained.
• Support design team to produce high quality, consistent design documents that meet the design control processes.
• Use the requirements management database tool extensively to manage design control documents, and the links between document content.
• Assist subject matter experts with writing, reviewing, and/or editing documents required by the design control process, including requirements, risk analyses, specifications, test protocols, and design review checklists.
• Coordinate documentation and Engineering Change Orders (ECOs) related to major design reviews.
• Produce requirements trace mapping and associated documentation.
• Use Siemens Polarion as a tool to accomplish the following:
o Enter and edit documents.
o Create and edit requirements and test cases.
o Create trace links
o Produce reports using standard report templates. Create additional custom reports as needed.
o Produce trace reports.
• Use Agile as a tool to accomplish the following:
o Organize and structure Design History Files (DHF) using Design Control checklists.
o Prepare and submit ECOs for individual documents and for DHF Bill of Material (BOM) changes.
• Work with the Technical Publications department to assure that Manuals, Instructions for Use, Labels and Training Materials are consistent with design documentation. Create trace documents and protocols used to assist in this process.
• Bachelor’s Degree in engineering or other technical area
• Ability to understand complex technical information and translate into writing
• Proven success recognizing critical issues with the ability to react quickly under pressure, and drive issues to closure by providing coordinated direction.
• Ability to manage challenging assignments and multiple assignments in parallel
• Strong planning, decision making, negotiating and change management skills
• Assertive, outgoing personality with an ability to work collaboratively within an engineering team
• Excellent writing and communication skills, and attention to detail
• Skilled in the use of Microsoft Excel, Microsoft Word, and Adobe Acrobat
• Minimum 8 years experience working in an ISO 9001 medical device product development environment or other regulated industry
• Experience writing and reviewing engineering (design control) documents, including specifications, test protocols and test reports
• Skilled in the use of Agile or similar lifecycle management system tool
• Skilled in the use of Integrity, Polarion or other requirements management tool
• Development experience with complex systems with a combination of hardware and software
• Experience in Risk Analysis and Failure Modes and Effects Analysis (FMEAs).
• Contract: 10 months (Part time - up to 30 hours per week)
• Pay Rate: $40 - $46 / hr
• Location: Raleigh, NC.
Benefits Package: Protingent offers competitive salaries, insurance plan options (HDHP plan or POS plan), education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO), and an administered 401k plan.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.