Medtronic is looking to solve design-focused issues within their released portfolio of Neuromodulation and Pelvic Health products by investigating problems to root cause and developing plans to implement fixes for both technical product issues and systemic issues identified in product development.
Requirements
- 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).
- 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.)
- Practitioner or certification in Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Lean Sigma tools, or similar.
- 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
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 across the NMPH product portfolio, and to concurrently manage multiple projects with different teams and while balancing competing priorities.
- Responsible for the ownership of desi gn - related CAPAs (Corrective and Prevent ive Action) within the Released Product Engineering (RPE) and develop products Quality Management System (QMS) spaces.
- Author investigation (i.e., root cause analysis) plans , reports, and supporting documents of a 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).
- Prov ide clear and concise communication – both written and verbal . Author strong documenta tion with attention-to-detail that is audit-ready . Present team’s investigation fin dings and action recommendations to quality (e.g., CAPA Board) and other management/business stakeholders.
- Plan schedule and resources ( e.g. , labor skillset s 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 con sensus , resolve disagreements , and assure sound decision-making.
Other
- Requires a Bachelors degree and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
- Three years of project and/or people management experience .
- Experience in medical device or highly regulated industry.
- Experience leading a complex project/program including cross functional team leadership, risk-based decision making, financial accountability, and ability to manage change implementation .
- Experience participating in or supporting audits or external inspections (e.g., FDA, TUV , internal audit ).
