Principal Project Manager

Principal Project Manager Spectraforce Technologies United States, California, South San Francisco Apr 21, 2026

Position Title:

Principal Project Manager Work Location:

South San Francisco, CA, USA Assignment Duration:

8

Months Work Schedule:

7 AM - 4 PM PST ( 1 hour lunch break)

Work Arrangement:

Onsite Position Summary This is a high-impact, dual-focus contract role, requiring deep experience in the Medical Device and Combination Product industry.

The role serves two key functions: operating as a Project Manager to drive the complex development program timeline execution, and acting as the QMS Specialist to ensure compliance with Client's Quality Systems. Background & Context This role is critical to ensuring successful execution of complex medical device and combination product programs through strong project management discipline and detailed timeline oversight.

Key Responsibilities Strategic Planning:

Translate device strategy into actionable plans, defining "inspection-ready" Design & Development Plans.

End-to-End Management:

Lead a range of projects including development pipelines, line extensions, and technology initiatives.

Team Performance:

Foster high-performing team dynamics, facilitating efficient decision-making, issue resolution, and cross-functional collaboration.

Governance & Business Gates:

Navigate teams through business process stage-gates and support technical advisory or governance committee reviews.

QMS Implementation:

Drive implementation, maintenance, and continuous improvement of the Quality Management System (QMS) including the tracking of metrics

Records Management:

Manage Design History Files (DHF) and document repositories to ensure accuracy, completeness, and regulatory compliance.

Audit Readiness:

Manages audit and inspection readiness, including preparation for internal audits and Health Authority inspections, and oversees timely remediation of findings.

Risk Mitigation:

Proactively identify project and compliance risks, developing robust contingency and mitigation plans.

Process Excellence:

Lead business process continuous improvement initiatives by applying lessons learned and optimizing PM tools.

Budget & Resources:

Forecast and monitor team resources, project costs, and budget tracking.

Qualification & Experience Education:

B.S. degree in Engineering, Technical Field, or a related discipline.

Experience:

At least 12 years in the Pharmaceutical or Medical Device industry. Minimum 5-6 years specifically in devices or combination products. Proven experience in drug/device development and commercialization.

Regulatory Expertise:

Extensive knowledge of

EU MDR, FDA 21 CFR

Parts 210, 211, & 820 (including 820.30 design controls), and

ISO 13485.

Project Management:

Proficiency in PM best practices and software; PMP certification is considered a significant asset.

Leadership:

Excellent professional presence with the ability to interact at all organizational levels and work with little to no supervision.