Principal Quality Engineer

In this role, you will apply your medical device design assurance expertise to ensure our medical devices are safe, effective, and delivered to our customers on time. You will work closely with several functions, including R&D Engineering (Systems, Mechanical, Electrical, Software, Test, Core Technology), Regulatory, Clinical, Usability, Product Management, and Operations/Manufacturing.

As a member of the QA/RA team, you will:

- Own the Design Assurance function and provide key leadership to new product development in the application of design controls.

- Support and continuously improve our Quality Management System (QMS) so that all design and development activity is fully compliant with global medical device regulations and standards.

- Act as the Design Assurance lead on new product development teams (e.g. core teams, risk management teams, manufacturing teams, etc.) to ensure that the appropriate documentation (DHF, DMR, Technical Documentation, etc.) is generated and can support our Class III IDE and PMA submissions.

You will be expected to use your professional experience to resolve complex issues and achieve our goals creatively and effectively. This role requires a drive to own the function and the versality to operate in a hands-on manner. This is the ideal role for a seasoned principal - level quality engineer who is seeking to own and influence the product design process throughout the product development process OR a well-rounded, senior - level candidate who is looking to make the jump to the next level.

Key Responsibilities

• Provide Design Assurance for NPD activities:

o Be a key contributor to the Quality Assurance function and provide leadership to all quality processes within the product lifecycle.

o Drive Risk Management process and activities.

o Collaborate with the R&D Engineering function in ensuring product development is properly documented and compliant with 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and other applicable US FDA and EU MDR regulations, standards, and guidance.

o Support the Software engineering function in implementing the software development process and software issue management activities throughout the product lifecycle.

o Author and review (as appropriate) documentation for the DHF, DMR, Technical Documentation, and other files.

o Be a primary reviewer of Design Transfer and Product Launch including in change assessment activities. 

• Be key contributor to the development of Third Pole’s Electronic Data Management System (EDMS) as the Subject Matter Expert (SME):

o Drive the continued implementation of new modules.

o Provide ongoing training and support to the company.

• Support QMS activities:

o Assist with Internal Audits as a qualified auditor/lead auditor.

o Participate in External Audits as key member of the Quality Team.

o Help to identify and drive continuous improvement of the QMS

• Acquire and maintain current knowledge of applicable global regulatory requirements and trends; develop strategy and provide internal guidance related to such trends.
• Conduct trainings and/or communicate appropriate materials to enhance the team’s/company’s knowledge of working in a regulated environment.
• Assist on other projects and tasks as required.

Must Haves

• Bachelor’s degree in life science or engineering.
• Minimum 10 years of medical device quality assurance experience that includes a minimum of 5 years in design assurance.
• Experience supporting regulatory submissions to FDA for medical devices (Class III preferred).
• Experience reviewing mechanical, software, and electronics design requirements and specifications.
• Expertise in application of medical device design controls.
• Hands-on experience with medical device hardware and software lifecycle processes and risk management including verification and validation activities.
• Current and working knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62304 and EU MDR.
• Proficiency with MS Office (Word/Excel/PowerPoint) and working knowledge of ALM and QMS software tools.
• Excellent verbal, listening and written communication skills.
• The temperament and the ability to be a motivated self learner
• Ability to prioritize and plan work activities, to problem solve, to adapt for changing conditions and to be a team player.
• Excellent documentation skills including record maintenance/tracking and an understanding of document traceability.
• Ability to work in a fast-paced team environment under pressure to meet critical timeframes as well as individually with minimal supervision.

Nice to Have

• Experience in drug/device development, cardiopulmonary disease and related therapies , hospital-based products, home use products, software-driven devices, and respiratory products.
• Experience with implementation of EDMS (Orcanos preferred).
• Experience with early stage product (clinical phase) development.
• Management, leadership, and mentoring skills.
• Familiarity with medical terminology a plus.