Engineering Program Manager - Release Product Engineering

Medtronic-posted 1 day ago
$140,800 - $211,200/Yr
Full-time • Mid Level
Minneapolis, MN
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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! 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 Parkinson's 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.

  • 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 sound, 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 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.
  • Requires a Bachelor's 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 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.
  • Health, Dental and vision insurance
  • Health Savings Account
  • Healthcare Flexible Spending Account
  • Life insurance
  • Long-term disability leave
  • Dependent daycare spending account
  • Tuition assistance/reimbursement
  • Simple Steps (global well-being program)
  • Incentive plans
  • 401(k) plan plus employer contribution and match
  • Short-term disability
  • Paid time off
  • Paid holidays
  • Employee Stock Purchase Plan
  • Employee Assistance Program
  • Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
  • Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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