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Medtech Project Manager information

What does a Medtech Project Manager do?

A Medtech Project Manager oversees the planning, execution, and delivery of projects related to medical technology, such as the development of medical devices or healthcare software. They coordinate cross-functional teams, manage timelines and budgets, and ensure compliance with regulatory standards. Their role is crucial in bridging the gap between technical development, clinical requirements, and business goals to bring innovative medical solutions to market efficiently and safely.

What are the key skills and qualifications needed to thrive as a Medtech Project Manager, and why are they important?

To thrive as a Medtech Project Manager, you need a strong background in project management, biomedical engineering or life sciences, and a solid understanding of regulatory requirements, often supported by a relevant degree and PMP or similar certification. Familiarity with project management software like MS Project or Jira, as well as knowledge of FDA/CE regulations and quality management systems, is typically required. Exceptional leadership, communication, and problem-solving skills help drive cross-functional teams and manage stakeholder expectations. These abilities ensure timely product development, regulatory compliance, and successful project outcomes in the highly regulated Medtech industry.

How does a Medtech Project Manager typically collaborate with cross-functional teams during the product development lifecycle?

A Medtech Project Manager frequently works with cross-functional teams, including R&D, regulatory affairs, quality assurance, marketing, and manufacturing. They coordinate efforts by facilitating regular meetings, setting clear timelines, and ensuring all team members are aligned with project goals and compliance requirements. Strong communication skills are essential, as the Project Manager must translate technical updates between departments and resolve potential roadblocks promptly. This collaborative approach helps deliver innovative medical technologies efficiently while meeting regulatory standards.

What is the difference between Medtech Project Manager vs Medical Device Engineer?

AspectMedtech Project ManagerMedical Device Engineer
Required credentialsBachelor's in engineering, project management certification (PMP)Bachelor's or higher in biomedical, mechanical, or electrical engineering
Work environmentProject teams, cross-functional collaboration, client interactionsDesign, development, testing, and manufacturing of medical devices
Employer & industry usageMedical device companies, healthcare tech firmsMedical device manufacturing, R&D departments
Common search & comparison intentUnderstanding project management roles in medtechTechnical engineering roles in medical device development

The Medtech Project Manager focuses on overseeing medical device projects, coordinating teams, and ensuring timely delivery. In contrast, a Medical Device Engineer is primarily involved in designing, developing, and testing medical devices. Both roles require engineering backgrounds, but their daily tasks and responsibilities differ significantly, catering to different aspects of the medical device lifecycle.

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What job categories do people searching Medtech Project Manager jobs in Utah look for? The top searched job categories for Medtech Project Manager jobs in Utah are:
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Medtech Project Manager jobs near you
Senior Quality Manager - Drug Products

Senior Quality Manager - Drug Products

Becton, Dickinson and Company

Sandy, UT • On-site

Full-time

Posted 9 days ago

BD rating

7.3

Company rating: 7.3 out of 10

Based on 138 frontline employees who took The Breakroom Quiz

265th of 430 rated machine equipment manufacturers

Job description

We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
Responsibilities:
  • Lead plant-wide Quality programs and compliance activities, overseeing CAPAs, non-conformances (QNs), planned deviations, and internal audit readiness across multiple departments
  • Drive Quality oversight for change control and engineering initiatives within the Drug Products function, ensuring alignment with regulatory and internal standards
  • Serve as a key member of the Quality Leadership Team, ensuring site compliance with procedures, regulatory requirements, and industry standards for medical device and pharmaceutical manufacturing
  • Champion continuous improvement initiatives as part of the Quality Steering Committee, driving quality system enhancements and supporting departmental and site-wide goals
  • Contribute to operational excellence projects, including blitzes, Six Sigma, and cross-functional improvement initiatives
  • Own Annual Product Reviews (APRs), ensuring thorough evaluation of product quality and compliance performance
  • Analyze quality data and trends to proactively identify risks and initiate improvement projects that address gaps and deficiencies
  • Empower and coach Quality teams, fostering a culture of accountability, continuous improvement, and compliance excellence
  • Partner cross-functionally with Quality, Production, and Engineering teams to identify root causes of quality issues and implement effective corrective actions
  • Prepare and deliver presentations for management reviews and site forums, ensuring clear communication of Quality performance and key insights
  • Lead and develop Quality team members, including engineers, technicians, and calibration staff, through:
    • Regular one-on-one engagement
    • Performance coaching and career development
    • Workload prioritization and resource planning
    • Recognition and employee engagement practices
  • Act as a subject matter expert (SME) on QMS and drug product regulations, mentoring cross-functional teams on requirements, expectations, and best practices
  • Serve as a delegate for the Plant Quality Associate Director, representing Drug Product Quality in cross-functional and site leadership discussions as needed
  • Support external audit readiness and execution, including FDA, ISO, corporate, and customer audits
  • Ensure full compliance with safety and environmental regulations, including RCRA hazardous waste requirements and all applicable BD policies
  • Uphold quality assurance standards and practices, ensuring consistent application of sound Quality principles across all operations

Required Qualifications:
  • Bachelor's degree with 8 years relevant experience or a combination of equivalent education and experience
  • Previous supervisory or management with 5 years relevant experience managing direct reports
  • Previous GMP experience with 5 years in Pharmaceutical, Drug Product, OTC and/or Combination Product experience

Preferred qualifications:
  • Degree in Engineering or Life Sciences
  • Six Sigma Certification

Knowledge and Skills:
  • Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measurable / confirmed results
  • Track record of root cause determination and effective corrective / preventive action implementation
  • Change management authorship, review, and/or approval
  • Validation and qualification authorship, review, approval, and/or execution such as (Install/Operational/Performance Qualification (IQ/OQ/PQ), Test Method Validation (TMV), and Measurement Systems Analysis (MSA).
  • Provides training for product development teams and continuous improvement teams on best practices
  • Conducts audits as member of a quality system audit team (e.g. SME, etc...)
  • Writes and leads risk management activities including risk management reports, risk assessment and risk analyses
  • Working knowledge of ISO 13485, FDA 21 CFR 211 and 820, and GMP requirements.
  • Root cause analysis methodologies (8D, A3, Fishbone, 5 Whys).
  • Skilled in Minitab, SAP, and TrackWise (or other ERP/QMS software).

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Annual Product Reviews, Business Audits, Compliance Programs, Continuous Improvement, Continuous Improvement Activities, Customer Audits, Ensure Compliance, External Audit, Internal Auditing, Non-Conformance Reporting (NCR), Pharmaceutical Products, Quality Management, Quality Management Systems (QMS), Safety Standards
Optional Skills
Six Sigma Project Management
Primary Work Location
USA UT - Sandy
Additional Locations
Work Shift
NA (United States of America)

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BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Industry

Medical equipment and supplies manufacturing and manufacturing

Company size

10,000+ Employees

Headquarters location

Franklin Lakes, NJ, US

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