What are the responsibilities and job description for the Sr. Manager / Director, Technical Program Management position at Vipany Global?
Job Details
Urgent requirement - Sr. Manager / Director, Technical Program Management- - Santa Clara, CA -United states
Job Description
- Lead and manage TPM in planning, coordinating and tracking deliverables across Precision's programs.
- Drive the execution of programs from concept through commercialization, ensuring all milestones, dependencies, and deliverables are met.
- Maintain timelines, budgets, and resources while adjusting plans as necessary based on project progress or risk mitigation.
- Develop tools and prepare reports to track deliverables and key performance indicators (KPIs), allowing regular updates to the leadership team on active company projects including those that you directly manage.
- Partner with cross-functional teams including strategic program management, hardware, software, electrophysiology, clinical, regulatory, and quality teams.
- Provide input into the development of overall program objectives, milestones, and KPIs.
- Build trust and foster effective working relationships with cross-functional peers in product, hardware, clinical, firmware, software, regulatory, and quality teams.
- Serve as a key point of contact for external R&D consultants and contractors, including manufacturing partners and suppliers.
- Collaborate with external partners to ensure alignment and adherence to the program's objectives, timelines, and quality requirements.
- Ensure compliance with FDA and global medical device regulatory standards, specifically under 21 CFR Part 820.
- Support verification and validation (V&V) activities, ensuring that the product meets regulatory requirements, including Class II and Class III medical devices.
- Drive process improvements to enhance project team productivity and overall quality.
- Hold team members, peers, and leadership accountable for meeting project objectives and timelines.
- Foster a culture of ownership, bias toward action, and urgency within the organization, ensuring rapid decision-making and execution.
Skills, Knowledge and Expertise
- Bachelor's degree in engineering, computer science or applied physics or a related field. An advanced degree is preferred.
- At least 7 years of experience as a Technical Program Manager, demonstrating increasing responsibilities including at least 2 years of supervisory management. For the Director role, at least 10 years of experience, with responsibilities including management of a department such as a program management office.
- Proven track record of driving complex cross-functional programs to product launch.
- Experience leading medical device projects through regulatory processes such as 510(k), DeNovo, or PMA.
- Experience with Class II and Class III medical device development under 21 CFR Part 820.
- Strong understanding of verification and validation (V&V) activities for hardware and software projects.
- Experience managing suppliers (both domestic and international) for hardware components and subassemblies (mechanical, electrical) and software development.
- Strong communication skills, with the ability to effectively convey complex ideas to technical and non-technical audiences
Preferred Qualifications:
- Prior experience in leading medical device development teams from R&D through to commercialization.
- Experience working with both internal stakeholders and external partners in a fast-paced, matrixed organization.
- Familiarity with agile methodologies and tools to manage projects effectively.
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