Position Summary:

The Engineering Director – Product Engineering position oversees project management and addresses supply and design-related matters for the released portfolio of company products. The company device is a medical system integrating multiple engineering disciplines, utilizing both capital equipment and disposable components to support liver transplants and improve organ availability.

Responsibilities include developing new features within the lifecycle management of the current product range. This role involves leading cross-functional teams to identify issues, develop corrective action plans, and implement solutions related to both technical product matters and broader product development challenges. This position requires interaction with upper management for project reporting and phase reviews. The role encompasses experience with various therapies, products, and operational considerations connected to patient care and business objectives.

Major Responsibilities:

As the leader of a small multi-disciplinary Product Engineering team, and under the direction of the SVP, Product Engineering, the successful incumbent will drive activities in the following areas:

• Lead cross-functional team members to ensure clear communication and coordination of project/program objectives, deliverables, and timing of key milestones.
• Orient quickly to understand new quality issues based on field or factory performance, and to concurrently manage multiple projects with different teams and while balancing competing priorities.
• May take direct responsibility for design-related CAPAs (Corrective and Preventive Action) within the Product Engineering department as well as process focused CAPAs.
• Author investigation (i.e., root cause analysis) plans, reports, and supporting documents of high quality (i.e., submission and audit/inspection ready) that are technically sounds, critically reasoned, and use appropriate root cause tools/methodologies (e.g., 5-Whys/Cause Map, Contradiction Matrix, other DRM/Six Sigma problem-solving and statistical analyses).
• Provide clear and concise communication – both written and verbal.
• Author strong documentation with attention-to-detail that is audit-ready.
• Present team’s investigation findings and action recommendations to quality (e.g., CAPA Board) and other management/business stakeholders.
• Plan schedule and resources (e.g., labor skills sets and duration, expenses) to achieve desired project outcomes.
• Responsible for maintaining a focus on quality, while effectively partnering with Quality, R&D, Operations, and Regulatory stakeholders to facilitate consensus, resolve disagreements, and ensure sound decision-making.
• Adhere to the letter and spirit of the Company Code of Conduct and all other company policies

Skills & Experience

• Experience in the medical device or highly regulated industry.
• Experience or technical education in software development, software or computer engineering, and/or software quality assurance, including knowledge of IEC 62304 (Medical device software – software life cycle processes).
• Experience with medical device systems that include software applications and/or embedded software (i.e., firmware).
• Experience leading a complex project/program, including cross-functional team leadership, risk-based decision making, financial accountability, and ability to manage change implementation.
• Background with CAPA (Corrective and Preventive Action) process, and/or experience with the use of root cause investigation, problem-solving, or similar structured methodologies and tools (e.g., 5-Whys, Fishbone, etc.)
• Experience participating in or supporting audits or external inspections (e.g., FDA, TUV, internal audit).
• Proven experience in achieving results through influence management and motivating teams.
• Knowledge and/or experience with product development processes and/or QMS (Quality Management System) Design Control procedures.
• Strong understanding of global regulatory requirements for medical devices, including FDA regulations (e.g., 21CFR Part 820), ISO 13485, Medical Device Directive, and European Medical Device Regulation.
• Working knowledge of Project Management methodologies and tools, including Project Management Professional (PMP) trained or certified

Qualifications:

• Requires a bachelor’s degree in engineering and a minimum of 5 years of relevant experience, or an advanced degree with a minimum of 3 years of relevant experience.
• Certified practitioner in Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), or Lean Sigma methodologies.
• Ability to travel 15%