Project/Program Manager-Device Engineering
3 weeks ago
Company Profile:
Our long-standing client a leading pharmaceutical company are seeking an experienced R&D Project Manager specialized in device engineering on an initial 11-month contract. The company possess a significant manufacturing and R&D presence that's been maintained via astute and robust capital investment. The site prides itself on being on the forefront of cutting‑edge R&D and delivering high quality products while focusing on niche therapeutic areas. If interested just apply below or if you'd like more information reach out to myself for a confidential conversation.
Key Responsibilities:
- Provides leadership and centralized management for the planning, development and execution of technical projects to achieve critical strategic business objectives. Manages multiple, often concurrent projects and consistently meets expectations.
- Competent in making difficult decisions regarding priorities among projects / programs while ensuring the buy in of teams and leaders
- Manages and is responsible for all phases of project execution including stage gate reviews, design reviews, etc.
- Develops methods, procedures and metrics for projects (scope, schedule, quality and cost) and reporting. Monitors and controls implementation plan in accordance with defined scope
- Competent in conducting risk assessments for technical and project related issues and developing mitigation plans to ensure project schedule and costs are maintained
- Responsible for the successful execution of significant technical projects. Through proper planning, ensures that scope, schedule, cost and customer expectations are met. Maintains a clear focus on life cycle costs
- A technical / engineering background in new product development and sustaining engineering within the medical device sector.
- Strong understanding of medical device regulations including FDA standard 21 CFR Parts 801 and 820, design controls, ISO13485, regulatory audits and international environmental regulations. Extensive experience and track record of success in the development of 510K/PMA regulated products required.
Essential Requirements:
- Degree and / or Masters in engineering or technical field with 5+ years of new product development (medical device engineering) and/or 5+ years of applicable project or program management experience in medical devices, healthcare or pharma development environment.
- A minimum of 5 years' experience and a proven track record in: Applying project management tools to manage New Product Development Programs, Applying project management tools to manage Sustaining Engineering Projects, Applying knowledge of ISO standards and FDA Design Control regulations
- Experience in development of complex sophisticated software controlled electromechanical medical devices with verification & validation activities is a plus.
- Experience in development of complex sterile disposable medical devices including plastic injection molding, extrusion and assembly methods is a plus
- Certification in Process Excellence (Green Belt or Black Belt) or project management certification PMP is a plus.
- Experience in outsourced medical device manufacturing, manufacturing technologies and process development is a plus
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