8+ years managing new product development in regulated industries, preferably medical devices
Proven leadership of cross-functional teams and complex programs
Strong data-driven decision-making skills
In-depth knowledge of ISO and FDA regulations and design control procedures
Expertise in risk management throughout program lifecycles
Responsibilities
Manage cross-functional teams to achieve program objectives
Develop integrated schedules and implement risk mitigation strategies
Ensure compliance with ISO and FDA regulations using phase/gate processes
Prepare and present program updates to stakeholders
Advocate for process improvements and foster a culture of efficiency
Implement new tools and educate teams on PMO initiatives
Mentor team members for growth and knowledge sharing
Benefits
On-site position requiring presence 5 days a week
Opportunity to lead innovative medical device initiatives
Engagement in a culture of continuous improvement
Access to professional development and mentoring opportunities
Collaboration with high-performing cross-functional teams
Full Job Description
SUMMARY
The primary responsibility of the Program Manager is to spearhead complex, multi product initiatives that deliver innovative medical devices to market. The candidate will play a pivotal role in driving strategic execution across product development teams. You will manage cross functional projects from early concept through commercialization, ensuring delivery of high quality, innovative medical products on time and within budget. This role requires strong leadership, collaboration, and communication skills to manage complex projects, align stakeholders, and proactively address risks and dependencies. You will be responsible for guiding strategically critical programs, facilitating decision making, and ensuring transparency of progress and outcomes across the organization.
PRINCIPAL DUTIES AND RESPONSIBILITIES
Manage Cross-Functional Teams: Guide high-performing teams to achieve program objectives while ensuring seamless collaboration across functions
Drive Program Success: Develop integrated schedules, identify critical paths, and implement robust risk mitigation strategies to deliver programs on time and within scope.
Ensure Compliance: Utilize phase/gate processes to execute programs in alignment with ISO and FDA regulations, ensuring adherence to design control procedures and quality systems.
Communicate with Impact: Prepare and present program updates, facilitate reviews, and engage stakeholders to drive alignment and program success.
Champion Innovation: Advocate for process improvements, implement new tools and technologies, and foster a culture of efficiency and continuous improvement.
Develop PMO organization: Implement new tools, templates, and technologies. Educate cross-functional resources on PMO initiatives and ensure consistent adherence to established processes and standards.
Mentor and Develop: Guide and mentor team members to support their growth, development, and knowledge sharing.
This is an on-site position, requiring to be on-site 5 days a week.
EXPERIENCE REQUIREMENTS
8+ years of experience managing new product development programs in regulated industries, preferably medical devices
Demonstrated ability to lead cross-functional teams and manage complex programs
Ability to make data-driven decisions and manage ambiguity
In-depth understanding of medical device industry standards as well as ISO and FDA regulations, including design control procedures.
Expertise in risk management and dependency mitigation throughout program lifecycles.
EDUCATION REQUIREMENTS
Bachelor's degree in Engineering, Business, or related field.
PMP certification is beneficial but not required.
OTHER QUALIFICATIONS
Proficiency in project management tools such as Microsoft Project and
dashboards.
Exceptional leadership, communication, and influence management skills to foster collaboration across matrix organizations.
Proven ability to manage multiple large-scale projects simultaneously in varying
lifecycle stages.
A proactive problem-solver with a strong work ethic, excellent organizational skills,
and a passion for accountability, collaboration, and innovation.
