Job Description

Title: Program Manager – R&D (Medical Devices)

Location: Santa Clara, CA (Onsite)

Contract Type: W2, 1-Year Contract

Rate: $65 – $70/hr

About the Role

We are seeking an experienced Program Manager to lead cross-functional teams in developing and commercializing new products within an R&D environment. This position manages programs of small to medium scope, or a significant subsection of a larger program, with direct accountability for achieving milestones, delivering results, and driving innovation.

The ideal candidate will bring strong leadership and technical acumen to guide multidisciplinary teams through all phases of product development. You will collaborate closely with engineering, quality, manufacturing, and senior leadership to ensure successful execution and compliance with medical device regulations.

What You’ll Work On

• Lead cross-functional teams through project planning exercises to develop detailed schedules and integrated project plans.

• Utilize project scheduling tools such as Microsoft Project and Smartsheet to plan and track project activities.

• Communicate objectives, risks, and program needs across all levels of the organization.

• Manage program scope, schedule, and resources to ensure successful completion of project deliverables.

• Establish and maintain the Design History File (DHF) in partnership with the Program Director and team members.

• Direct project execution by assigning tasks, tracking progress, identifying risks, and developing contingency plans.

• Collaborate with team members to eliminate or mitigate risks, escalating issues when necessary.

• Partner with leadership to identify opportunities for improving program performance.

• Mentor and guide functional core team leaders when appropriate.

• Ensure project quality by following standard methodologies and working with Quality Engineering to develop and execute quality plans.

• Resolve project issues through effective communication and collaboration.

• Prioritize tasks, set objectives, and apply the most effective methods to ensure project success.

• Maintain a safe, professional work environment in compliance with FDA , ISO , and Good Manufacturing Practices (GMP) regulations.

Required Qualifications

• Bachelor’s Degree in Engineering, Science, or a related technical field .

• Minimum 5+ years of progressively responsible experience in engineering, program management, or related technical disciplines.

• Proven expertise in Project Management tools and methodologies .

• Demonstrated success leading complex, cross-functional projects from concept through commercialization.

• Strong organizational, analytical, and communication skills.

• Ability to effectively lead matrixed resources and drive accountability across functions.

Preferred Qualifications

• PMP (Project Management Professional) certification preferred.

• Proficiency with MS Project , Smartsheet , and other project management platforms.

• Strong leadership, influencing, and negotiation skills.

• Experience working with complex mechanical or electromechanical devices .

• Working knowledge of medical device regulations and standards (FDA, ISO, QSR design controls).

• Familiarity with Phase Gate processes and R&D lifecycle management.

• Proven ability to gain trust, build rapport, and communicate effectively across teams.

Eligibility

Must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. Blue Star Partners LLC will not sponsor applicants for U.S. work visa status for this opportunity (no sponsorship available for H-1B, L-1, TN, O-1, E-3, H-1B1, F-1, J-1, OPT, CPT, or any other employment-based visa).

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