Medtronic
Engineering Program Manager - Release Product Engineering
Medtronic, Minneapolis, Minnesota, United States, 55400
Engineering Program Manager - Release Product Engineering
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This position is based in Fridley, MN supporting the Neuromodulation and Pelvic Health Operating Units. This is a hybrid role with the requirement of being onsite at Medtronic’s Rice Creek facility an average of 4 days per work week.
A Day in the Life: In this role 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 interfaces with upper management for project reporting and phase reviews. This is a dynamic role that exposes 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.
Product focus
The candidate will work on Neuromodulation and Pelvic Health therapies and related implantable and external devices, software programming applications, and related tools. The following are representative therapy areas and products: Neuromodulation (SCS, DBS, PH, TDD, Interventional Pain systems) and Pelvic Health (sacral neuromodulation) systems. This is a senior engineer/managerial role focused on quality, regulatory readiness, and cross-functional collaboration to ensure robust design and sustained performance of released products. Responsibilities Lead cross-functional team members to ensure clear communication and coordination of project/program objectives, deliverables, and timing of key milestones. Understand new quality issues across the NMPH product portfolio and concurrently manage multiple projects with different teams while balancing competing priorities. Own design-related CAPAs within Released Product Engineering (RPE) and contribute to Quality Management System (QMS) spaces. Author investigation plans and reports (root cause analyses) that are audit-ready and reference appropriate tools and methodologies (e.g., 5-Whys, Cause Map, DMAIC) as needed. Provide clear written and verbal communication; present investigation findings and action recommendations to Quality and other stakeholders. Plan schedule and resources (labor, duration, expenses) to achieve desired project outcomes. Maintain a focus on quality while partnering with Quality, R&D, Operations, and Regulatory stakeholders to facilitate consensus and sound decision-making. Minimum Requirements 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. 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. Experience with medical device systems that include software applications and/or embedded software (firmware). Experience leading a complex project/program with cross-functional leadership, risk-based decision making, financial accountability, and change management. Background with CAPA processes and use of root cause investigation tools (e.g., 5-Whys, Fishbone). Design for Reliability/DFSS, Lean Sigma tools, or related. Experience participating in or supporting audits or external inspections (e.g., FDA, TUV). Proven experience in achieving results through influence management. Knowledge of product development processes and QMS Design Control procedures. Strong understanding of global regulatory requirements for medical devices (FDA 21 CFR Part 820, ISO 13485, MDR). Working knowledge of project management methodologies and tools; PMP trained or certified is a plus. Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. Salary ranges for U.S. locations: $140,800.00 - $211,200.00. This position is eligible for the Medtronic Incentive Plan (MIP). The base salary range may vary based on experience, certification/education, market conditions, and location. Benefits include health, dental, vision insurance; 401(k) with company match; paid time off; holidays; employee stock purchase plan; and more, with details at the provided link. Equal Employment Opportunity It is the policy of Medtronic to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, gender, sexual orientation, gender identity and/or expression, genetic information, marital status, veteran status, or any other characteristic protected by law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities. It is the policy of Medtronic to provide equal opportunities in the Los Angeles County area under local Fair Chance Ordinances; see the company policy for details. Medtronic is an equal opportunity employer and participates in the colorado fair chance act as applicable. Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering and Information Technology Industries: Medical Equipment Manufacturing, Hospitals and Health Care, and Pharmaceutical Manufacturing
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The candidate will work on Neuromodulation and Pelvic Health therapies and related implantable and external devices, software programming applications, and related tools. The following are representative therapy areas and products: Neuromodulation (SCS, DBS, PH, TDD, Interventional Pain systems) and Pelvic Health (sacral neuromodulation) systems. This is a senior engineer/managerial role focused on quality, regulatory readiness, and cross-functional collaboration to ensure robust design and sustained performance of released products. Responsibilities Lead cross-functional team members to ensure clear communication and coordination of project/program objectives, deliverables, and timing of key milestones. Understand new quality issues across the NMPH product portfolio and concurrently manage multiple projects with different teams while balancing competing priorities. Own design-related CAPAs within Released Product Engineering (RPE) and contribute to Quality Management System (QMS) spaces. Author investigation plans and reports (root cause analyses) that are audit-ready and reference appropriate tools and methodologies (e.g., 5-Whys, Cause Map, DMAIC) as needed. Provide clear written and verbal communication; present investigation findings and action recommendations to Quality and other stakeholders. Plan schedule and resources (labor, duration, expenses) to achieve desired project outcomes. Maintain a focus on quality while partnering with Quality, R&D, Operations, and Regulatory stakeholders to facilitate consensus and sound decision-making. Minimum Requirements 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. 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. Experience with medical device systems that include software applications and/or embedded software (firmware). Experience leading a complex project/program with cross-functional leadership, risk-based decision making, financial accountability, and change management. Background with CAPA processes and use of root cause investigation tools (e.g., 5-Whys, Fishbone). Design for Reliability/DFSS, Lean Sigma tools, or related. Experience participating in or supporting audits or external inspections (e.g., FDA, TUV). Proven experience in achieving results through influence management. Knowledge of product development processes and QMS Design Control procedures. Strong understanding of global regulatory requirements for medical devices (FDA 21 CFR Part 820, ISO 13485, MDR). Working knowledge of project management methodologies and tools; PMP trained or certified is a plus. Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. Salary ranges for U.S. locations: $140,800.00 - $211,200.00. This position is eligible for the Medtronic Incentive Plan (MIP). The base salary range may vary based on experience, certification/education, market conditions, and location. Benefits include health, dental, vision insurance; 401(k) with company match; paid time off; holidays; employee stock purchase plan; and more, with details at the provided link. Equal Employment Opportunity It is the policy of Medtronic to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, gender, sexual orientation, gender identity and/or expression, genetic information, marital status, veteran status, or any other characteristic protected by law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities. It is the policy of Medtronic to provide equal opportunities in the Los Angeles County area under local Fair Chance Ordinances; see the company policy for details. Medtronic is an equal opportunity employer and participates in the colorado fair chance act as applicable. Seniority level: Mid-Senior level Employment type: Full-time Job function: Engineering and Information Technology Industries: Medical Equipment Manufacturing, Hospitals and Health Care, and Pharmaceutical Manufacturing
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