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OrganOx · 11 hours ago

Director, Product Engineering

Madison, NJ

Full-time

Onsite

Lead/Staff, Director/Executive

$185K/yr - $205K/yr

5+ years exp

OrganOx is an innovative global medical device company dedicated to improving transplantation outcomes. The Engineering Director - Product Engineering will oversee project management for the OrganOx metra® NMP products, leading cross-functional teams to address supply and design-related matters while developing new features and ensuring quality standards.

Health CareMedicalMedical Device

Responsibilities

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

Qualification

Medical device experienceSoftware development knowledgeRegulatory knowledgeProject management skillsCAPA process experienceRoot cause analysisQuality Management SystemTeam leadershipCommunication skillsAttention to detail

Required

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

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

Ability to travel 15%