Hybrid Director, Product Engineering

at OrganOx

• Job title: Director, Product Engineering
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: PMP
• Location requirements: Hybrid, Madison, United States

About the role

• Director of Product Engineering at OrganOx leading a multi-disciplinary team in medical device project management. Responsible for enhancing organ transplantation outcomes through innovative technology.

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 OrganOx’s Code of Conduct and all other company policies

Requirements

• Skills & Experience
• Experience in 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 minimum of 5 years of relevant experience, or 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%

Benefits

• We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development.
• We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.