Project Manager - Medical Device Contract Manufacturing Location: Pittsburgh, PA
Reports To: NPI Engineering Manager
Cadence is more than a company - we're a catalyst for a healthier future, driven by the purpose to advance patient outcomes through precision engineering. We partner with world-class MedTech and Pharma innovators who entrust us to collaborate, assemble and deliver complex, complete devices and precision components with impeccable quality. Together, we're developing the solutions of tomorrow.
We are seeking an experienced Project Manager to lead and manage cross-functional teams in the delivery of high-quality, on-time, and on-budget medical device manufacturing projects. The Project Manager will work closely with customers, internal teams, and external partners to ensure the successful execution of product development, manufacturing transfers, and commercialization efforts. This role requires a deep understanding of medical device manufacturing, regulatory requirements, and the ability to manage multiple projects simultaneously in a fast-paced contract manufacturing environment.
Key Responsibilities - Project Leadership & Execution: Lead and manage all phases of the commercialization of medical device projects as they are engineered from initiation through transfer to manufacturing, ensuring adherence to timelines, budgets, and quality standards. Focus on the attainment of desired outcomes.
- Customer Liaison: Serve as the primary point of contact for customers, providing regular project updates, managing expectations, and ensuring alignment with customer goals and requirements.
- Cross-functional Collaboration: Work closely with engineering, quality, supply chain, production, and site teams to align responsibilities and due dates in support of project activities; resolve issues; manage scope; and ensure successful project execution.
- Risk Management: Identify potential risks and implement mitigation strategies to ensure project objectives are met with minimal disruptions.
- Regulatory Compliance: Ensure all projects comply with FDA, ISO 13485, and other relevant medical device industry regulations and standards.
- Timeline & Resource Management: Develop and maintain project schedules, manage resource allocation, and monitor progress to ensure that project deliverables are met.
- Budget Management: Track project budgets, manage costs, and report on financial performance, ensuring profitability and cost control throughout the project lifecycle.
- Documentation & Reporting: Maintain detailed project documentation, including timelines, budgets, status reports, and change control processes, ensuring all stakeholders have clear visibility of project progress.
- Process Improvement: Drive continuous improvement in project management processes and practices, fostering a culture of operational excellence.
Qualifications - Willingness and ability to work primarily on-site at our Cranberry Township, PA location.
- Education:
- Bachelor's degree in Engineering, Business, or a related field.
- Project Management Professional (PMP) certification is preferred.
- Experience:
- 5 years of project management experience in the medical device, life sciences, or contract manufacturing industry.
- Proven track record of managing complex, multi-disciplinary projects from concept to completion, including product development and manufacturing transfers.
- Experience working with FDA regulations, ISO 13485, and other medical device industry standards.
- Skills:
- Strong leadership and organizational skills with the ability to manage multiple projects and teams simultaneously.
- Excellent communication and interpersonal skills to manage customer relationships and collaborate with cross-functional teams.
- Strong problem-solving skills and the ability to navigate challenges and provide solutions under pressure.
- Proficiency with project management tools and software (e.g., MS Project, Smartsheet, Celoxis, or equivalent).
- Competencies:
- Attention to detail with a meticulous approach to managing project documentation and ensuring regulatory compliance.
- Strong customer focus, dedicated to meeting the expectations and requirements of internal and external customers.
- Comfortable working in a dynamic, fast-paced environment with shifting priorities.
- Ability to inspire, motivate, and guide teams toward achieving project goals.
Why Join Us? - Work in an innovative and dynamic contract manufacturing company that focuses on producing life-changing medical devices.
- Collaborate with talented professionals committed to excellence in quality, operational performance, and customer service.
- Opportunity for career growth and professional development in the rapidly evolving medical device manufacturing industry.
