Senior Product Engineer

Position Summary

The Senior Product Engineer is a primary problem solver for our operations team; working within our QMS to resolve tactical issues and strategically improve our products. This role ensures product requirements are met, operations objectives are achieved, and continuous improvement plans are developed and executed. This person reacts to and resolves issues in operations as well as defines, develops, and executes improvements to the product quality, service, and cost throughout the supply chain. This person will identify, scope, and lead operations objectives to drive sustaining efforts related to existing products and to facilitate production readiness of new products. They will also provide subject matter expertise to influence and inform future objective planning for engineering-related objectives.

Accountabilities & Responsibilities

• Independently identify and plan continuation roadmaps, and execute continuation engineering activities required for ongoing production success.
• As a product SME and technical leader, drive project objectives with minimal oversight ensuring project milestone progression is clearly communicated and understood by cross-functional partners.
• Identify and lead sustaining engineering activities with vendors to support quality, cost, and delivery improvements.
• Serve as SME for product use, design requirements, process validation, and design validation requirements.
• Provide input to and upkeep product risk management documentation.
• Evaluate and respond to key metrics influenced by engineering to prioritize day-to-day and strategic planning.
• Proactively identify procedural/QMS gaps and lead efforts to implement fixes.
• Actively participate in CAPAs through investigation and corrective action ownership as assigned.
• Anticipate the needs and requirements of core-team partners (Quality, Supply Chain, Production).
• Influence AOP process to ensure the continuation and product roadmaps are supported.
• Maintain alignment with new product commercialization project team through effective communication.
• Ensure design transfer deliverables meet requirements of production through execution and oversight.
• Train production team on new and updated work instructions.
• Review and disposition NCMRs generated in operations. Engage with MRB to determine complex disposition plans.
• Respond to the needs of production through action.
• Develop and maintain work instructions for manufacturing processes.
• Navigate and work within QMS systems.
• Other duties as assigned.

Education & Experience

Required:

• Bachelors Degree in a technical discipline
• 6+ years of work experience in a related field

Preferred:

• Experience in Medical Device or regulated industry
• Experience in soft-goods manufacturing and design

Knowledge & Skills

• Working knowledge of MS Office software applications (Word, Excel, Project, Visio, etc.)
• Strong written/verbal communication and presentation skills to clearly articulate concepts
• Ability to work cross-functionally to solve technical problems
• Demonstrated ability to meet project deadlines
• Ability to make timely decisions based on stakeholder input and engineering fundamentals
• Organization and prioritization skills - adaptable to changing business needs and adept at juggling and prioritizing numerous projects
• Demonstrated problem solving skills and analytical abilities
• A passion for continuous learning
• Ability to collaborate with both technical and non-technical team members

Competencies

• Action Orientated
• Directing Others
• Influencing
• Flexible
• Functional/Technical Skills
• Teamwork
• Communication
• Process oriented
• Priority Setting
• Problem Solving

It is the policy of Tactile Medical to provide equal opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Tactile Medical will provide reasonable accommodations for qualified individuals with disabilities.