Engineering Program Manager - Release Product Engineering bei Medtronic
Medtronic · Minneapolis, Vereinigte Staaten Von Amerika · Hybrid
- Senior
- Optionales Büro in Minneapolis
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
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 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.
This is a hybrid position 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
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 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.
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
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.