Program Director-EU MDD/MDR Design Compliance

Job Title

Job Description

The Program Director-EU MDD/MDR Design Compliance will play a critical role in ensuring the Quality, Safety, and global compliance of Philips’ Sleep & Respiratory (S&RC) products through leading program Design and Construction deliverables across S&RC, with a focus on product technical file completion and driving Program governance, education, and standardization.

Your role:

• The Program Director-EU MDD/MDR Design Compliance drives simplification, standardization, and compliance in the global sites through a variety of programs and processes, with a focus on electromechanical design, technical file requirements, end-of-life process (EOL), and CAPA management. 
• The Program Director will provide vision, strategy, and technical depth in the focus areas, as well as integrating self-audit findings and best practices from other businesses across Philips into the global S&RC product portfolio. 
• Directly leads a portfolio of projects with accountability for the end-to-end program plan & schedule (both top-down org requirements and bottoms-up team requirements) and resolve interdependence within and across the program. Will also set up PMO governance, processes, and procedures including tiered daily management to communicate status, escalations, etc. with executives at various levels within/outside of S&RC and may utilize project leaders within/outside PPM to ensure appropriate capability and staffing.
• Reporting to the S&RC PPM Leader, you will partner with the business segments, R&D, and manufacturing leadership to ensure the portfolio meets today’s needs and is aligned with product roadmaps to deliver on our commitments to our patients. 

You're the right fit if:

• You’ve acquired a minimum of 10+ years’ experience in strategic/functional program/portfolio leadership in FDA regulated Medical Device, matrixed organizations, with strong knowledge in innovation, product development, operations etc.
• You have proven expertise in all aspects of program planning and execution, demonstrating an outstanding record of project management success, both in results achieved and in use of professional methodology. 
• You have detailed knowledge of Quality System Regulations (EU MDD/MDR, ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of European medical device regulations, directives, and standards.
• You’ve influenced a broad range of stakeholders, and able to effectively communicate at all levels, including peer-to-peer relationships with executive business/market leaders and content experts.
• You’re a self-starter, skilled in driving continuous improvement in a matrixed environment, leading process improvement methodologies (e.g., Lean, Hoshin or 6-sigma).
• You have a minimum of a Bachelor’s Degree (Required), Master’s degree/MBA desired. PMP Certification preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. 

How we work together:

We believe that we are better together than a part. 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 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 position in Murrysville, PA, New Kensington, PA, is $159,000 to $254,000.
• The pay range for this position in Cambridge, MA is $178,332 to $285,331.

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.    

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. 

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. 

Additional Information:

• Company relocation benefits will not be provided for this position.  For this position, you must reside in or within commuting distance to Murrysville PA or New Kensington, PA or Cambridge, MA.
• May require travel up to 10%.

#LI-PH1

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.