In this exciting role as an Engineering Program Manager Released Product Engineering you will have responsibility for project management and leadership for the investigation and resolution of design-focused issues associated with the performance of the released portfolio of Neuromodulation and Pelvic Health products. You will lead cross-functional teams to investigate problems to root cause and to develop plans and implement actions to fix both technical product problems and address systemic issues identified in product development. This role will also provide opportunities to interface with upper management for project reporting and phase reviews. This is a dynamic role that will expose the PM to a variety of therapies products and challenges that impact patients and drive business results.

Come help make a difference on work that directly impacts patients and serves the Medtronic Mission to alleviate pain restore health and extend life!

Insert a paragraph directly related to the product the candidate will be working on

This position is based in Fridley MN supporting the Neuromodulation and Pelvic Health Operating Units.

Neuromodulation products provide therapy for a variety of conditions including Chronic Pain Cancer Pain Severe Spasticity Epilepsy Dystonia Essential Tremor and Parkinsons Disease. The Neuromodulation therapies include implantable Spinal Cord Stimulation (SCS) Deep Brain Stimulation (DBS) Pelvic Health (PH) Targeted Drug Delivery (TDD) and Interventional Pain systems and products

Pelvic Health therapies treat patients suffering from overactive bladder non-obstructive urinary retention and fecal incontinence with our sacral neuromodulation (SNM) systems.

Products for these therapies including implantable and external neurostimulators implantable infusion pumps leads catheters associated software programming applications and associated device recharge and programming instruments.

This is a hybrid position with the requirement of being onsite at Medtronics Rice Creek facility an average of 4 days per work week.

A Day in the Life

• 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 design-related CAPAs (Corrective and Preventive 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).

• Provide clear and concise communication both written and verbal. Author strong documentation with attention-to-detail that is audit-ready. Present teams investigation findings and action recommendations to quality (e.g. CAPA Board) and other management/business stakeholders.

• Plan schedule and resources (e.g. labor skillsets 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 assure sound decision-making.

Must Have: Minimum Requirements (Standard Minimum Requirements will be uploaded from Workday)

To be considered for this role please ensure the minimum requirements are evident on your resume.

• Requires a Bachelors degree and minimum of 5 years of relevant experience or advanced degree with a minimum of 3 years of relevant experience.

Nice to Have (Preferred Qualifications)

• Three years of project and/or people management 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.)

• Practitioner or certification in Design for Reliability and Manufacturability (DRM) Design for Six Sigma (DFSS) Lean Sigma tools or similar.

• 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