Sr. Program Manager- Product & Process Development & Remediation, Consent Decree page is loaded
Sr. Program Manager- Product & Process Development & Remediation, Consent Decree
Apply locations Murrysville Plymouth Cambridge time type Full time posted on Posted Yesterday job requisition id 554032
Job Title
Sr. Program Manager- Product & Process Development & Remediation, Consent Decree
Job Description
Sr. Program Manager - Product & Process Development and Remediation, Compliance Programs
This role leads portfolio & program management initiatives for product remediation efforts tied to broad compliance initiatives such as European Medical Device Regulation (EU-MDR) and U.S. Consent Decree remediation. This role drives simplification, standardization, and product compliance with a focus on design & development, CAPA’s, and the associated process & production controls in our global manufacturing sites.
Your role:
* Providevision, strategy,and manage complex problems and address difficult issues. You, as the leader, understand broader implications and have technical depth of electromechanical design, design history file requirements, end-of-life process, Quality Systems (e.g., CFR Part 820) and CAPA management.
* Serve as program manager and lead cross-functional core teams, working to establish, maintain, and track scope, schedule, milestones, program risks and other key program management deliverables.
* Function as the portfolio manager and partner with the business and R&D leadership to ensure the portfolio meets today’s needs and is aligned with innovation and product roadmaps to deliver on our commitments to our patients.
* Manage audit outcomes and integrate self-audit findings into the processes that define our products.
* Be accountable for the program plan & schedule and resolve interdependence with other workstreams.
* Represent Product & Process Development and Remediation in Project Management Office (PMO)governance mechanisms. Act as the single point of accountability to communicate status, escalations, etc. with executives at various levels within Sleep & Respiratory Care (S&RC).
You're the right fit if:
* You’ve acquired 7+ years of related experience in program and portfolio management and have program management expertise in a matrixed environment with proven business experience in your domain (innovation, product development, quality assurance, operations etc.) in various roles.
* You have a bachelor’s required. PMP Certification preferred. A master’s degree in science, engineering, or a related field preferred,
* You have experience in leading process improvement methodologies (e.g., Lean, Hoshin or 6-sigma). Experience working to address larger compliance issues such as consent decrees, warning letters, 483s, recalls, and EU MDR remediation is strongly preferred.
* Your skills include a good understanding of the Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device development process requirements. You have a strong background in remediation efforts, and CAPA’s.
* You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
* You’re a counselor of a broad range of stakeholders, able to have a peer-to-peer relationship with executive business/market leaders and content experts. You have excellent executive communication skills.
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
This is an office-based role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
* Learn more about our business .
* Discover our rich and exciting history.
* Learn more about our purpose.
* Learn more about our culture.
Philips Transparency Details
The pay range for this role in Pittsburgh, PA is $124,500 to $199,200
The pay range for this in Plymouth, MN is $130,725 to $209,160.
The pay range for this role in Cambridge, MA is $139,440 to $223,104.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here .
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
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About Us
At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.
For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.
Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.
It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.
To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
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