Compliance Engineer

POSITION / JOB SUMMARY:

The Compliance Engineer is responsible for all technical and engineering documentation of their assigned projects while they plan and manage all the technical tasks for Single-Use Devices and Re-Usable Surgical Instruments to ensure accuracy and quality through their product lifecycle. This position will maintain technical documentation for worldwide distribution, including FDA and CE Mark registration, and maintain process validations for sterilization, packaging, and reprocessing. In addition, this role involves leading cross-functional teams and coordinating external resources while authoring, organizing, and maintaining test plans, protocols, and reports.

Position Responsibilities / Essential Functions:

Percentage Time

Accountability

50%

Product Support:

• Ensure products remain in conformance with US, EU, and rest of world regulatory requirements by developing test plans, protocols, and reports necessary to provide evidence of conformity.
• Lead design assurance teams including engineers for Human Factors, Biocompatibility, Packaging, Risk, Sterilization, and Manufacturing through product design, re-design, development, design transfer and Post Market Surveillance (PMS) activities.
• Oversee production sterilization activities to ensure products may be released to the market.
• Drive test method development and validation efforts with the test group, including identifying applicable standards and guidance, establishing acceptance criteria, and approving results.
• Perform gap analysis of relevant standards to determine actions needed to maintain technical documentation and declaration of conformance to state of the art.
• Take responsibility for the Risk Management process. Write, edit, and maintain risk management plans/reports, risk assessments (FMEAs), and hazard analyses.
• Provide engineering support in troubleshooting the manufacturing process with manufacturing partners.

50%

Follow Quality Systems/Design Control Processes:

• Coordinate, draft, and maintain documentation in support of ISO 13485 and FDA 820 quality systems, including design control, such as Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), Technical Construction Files (TCF), Work Instructions (WI), Manufacturing Procedures (MP), Bill of Materials (BOM), Etc.
• Investigate product complaints and participate in Corrective Actions/Preventative Action process.
• Facilitate identification of root cause for quality and clinical issues that arise for current products.

QUALIFICATIONS:

Required Qualifications:

Education:

• Bachelor's degree in Engineering, Sciences, or a related discipline

Experience:

• 5+ years of related work experience in a similar role within a regulated industry (i.e., medical device, pharmaceutical, aerospace, etc.), including quality management system (QMS) experience.
• Technical review and documentation updates to ensure compliance with quality system requirements
• Demonstrated skills in understanding and interpreting regulations, standards and laws in a regulated environment

Skills:

• Proficient with MS Office (Word, Excel, Outlook, OneNote), MS Project.
• Strong verbal and written communication with the ability to effectively communicate at multiple organizational levels.
• Ability to influence and indirectly lead, including in challenging situations.
• Must be self-directed with a sense of appropriate review and approvals.
• Demonstrated creative and effective problem-solving and original thinking for compliance solutions
• Ability to work on multiple tasks concurrently with changing priorities

Preferred Qualifications:

Experience:

• Experience with single-use device Packaging and Sterilization (gamma and ETO) maintenance and validations
• Experience with re-usable device Reprocessing (cleaning, thermal disinfection, steam sterilization)
• Experience with Biocompatibility
• Experience with Risk Management
• Design knowledge and/or processing experience with materials and processes such as stainless steel, titanium, nitinol, thermal plastics, and silicone, including extrusion, molding, machining, forging, heat treating, plating, welding, passivation, and electro-polishing.
• Experience with CE Mark products.

Skills:

• Ability to apply statistical methods and tools, including Determining sample size; Establishing confidence and reliability levels necessary with sound justification; Developing capability and/or process validation plans with statistically sound sample sizes and analysis.