Our mid-sized medical device client is adding a Sr. Sustaining Engineer to the team. This is a newly created position reporting to the Director of Quality. The Sr. Sustaining Engineer will be primarily maintaining existing commercialized products post transfer by ensuring the products remains safe, compliant and optimized for manufacturing process performance. There will also be an opportunity for some Design Assurance engineering support for products in development by driving and executing risk management and design control activities. This position is due to growth and will help shape the sustaining function. Experience working with R&D/Development is required. 

Your role with the company:

• Drive engineering activities for design and/or process changes to existing products by developing evidence-based project plans and executing on deliverables. Ensure strong cross-functional collaboration, timely multi-disciplinary input and compliance with regulatory standards and internal quality system requirements.
• Leads design verification, design validation, usability and test method validations activities for new product development and for design changes to meet or exceed internal and external requirements.
• Develop, drive execution, and implement design inputs and design outputs for changes to existing products. Develop new test methods and/or revise existing test methods to support the changes. Execute test method validations.
• Cross-functional leader for completion of Risk Management deliverables. Perform risk management assessment for changes.
• Manage Quality System processes necessary to properly document and assess sustaining activities.
• Perform root cause investigations, propose corrective actions and oversee their implementation by using problem solving tools.
• Support complaint investigation effort as needed, including returned product evaluation, testing, and health risk assessment.
• Support regulatory approvals and responses to regulatory agencies’ questions.
• Accountable for the implementation of opportunities to optimize/improve manufacturing processes and systems.
• Execute engineering change control efforts per established processes and manage the deliverables per QMS requirements.
• Coordinate design/process change implementation into production.

Desired Profile:

• BS or advanced degree in engineering or related discipline
• 5+ years medical device experience in engineering function
• Expert knowledge of Design Control and Risk Management
• Knowledge of problem-solving methodologies and approaches
• Experience with Quality Systems as outlined in CFR820/ ISO13485
• Experience leading CAPA investigations and developing effective corrective actions that utilize a risk-based approach
• Excellent facilitation and presentation skills
• Strong ability to communicate (written and verbally) within and across disciplines and organizational structures
• Ability to manage competing priorities in a fast-paced environment
• Demonstrated use of Quality tools and methodologies
• Practical knowledge of applied statistics, including statistical analysis tools (Minitab, JMP, etc.) High attention to detail, organization, and accuracy
• Ability to plan and implement technical tasks that may not be well-defined, have multiple variables and require advanced implementation techniques