Program Manager

Randstad USA; Dublin (CA); On-site; USD 83,000 - 92,000; Full time

Job summary

Randstad Engineering in Dublin, CA is seeking a seasoned Program Manager for a contract role. You will serve as the central program leader, driving alignment and execution across R&D, regulatory, quality, operations, and marketing teams, with emphasis on FDA-regulated medical device programs.

The ideal candidate brings 8+ years in a regulated medical device setting and has FDA 510(k) experience. This contract role runs at least 6 months and may extend, with 9am-5pm hours on-site in Dublin, CA.

Qualifications

• 8+ years of Program Management experience in a highly complex regulated medical device environment.
• FDA 510(k) global regulatory experience.

Responsibilities

• Direct programs through R&D, regulatory submission, commercial launch, and post-launch scale-up.
• Enforce Prometh+ development processes, design controls, and phase gate reviews.
• Unify Product Management, R&D, Regulatory, Quality, Operations, and Marketing teams.
• Coordinate regulatory submissions, clinical trial execution, and product approvals.
• Lead operational launch planning across manufacturing, supply chain, training, and customer service.
• Manage change control, system requirements, verification, validation, and risk management.
• Build and track integrated project plans, critical path milestones, and team resource allocation.

Skills

Program Management

Regulatory Affairs

Leadership

FDA 510(k)

Education

Bachelor's degree

Job description

Job Summary

Join a multi-billion dollar manufacturing organization for a contract role as a Program Manager in Dublin, CA. This role will be serve as a central program leader responsible for driving alignment and project execution across cross functional teams. An ideal candidate will have at least eight years of experience in an FDA- regulated environment with U.S. experience. This is a contract role that is expected to last at least 6 months (could be extended) and will work closely with cutting edge technology within the medical device industry.

Location & Contract Details

Location: Dublin, California
Job type: Contract
Salary: $60 - 67 per hour
Work hours: 9am to 5pm
Education: Bachelors

Responsibilities

• Direct programs through R&D, regulatory submission, commercial launch, and post-launch scale-up.
• Enforce Prometh+ development processes, design controls, and phase gate reviews.
• Unify Product Management, R&D, Regulatory, Quality, Operations, and Marketing teams.
• Coordinate regulatory submissions, clinical trial execution, and product approvals.
• Lead operational launch planning across manufacturing, supply chain, training, and customer service.
• Manage change control, system requirements, verification, validation, and risk management.
• Build and track integrated project plans, critical path milestones, and team resource allocation.

Qualifications

• 8+ years of Program Management experience in a highly complex regulated medical device environment
• FDA 510(k) global regulatory experience

#randstadengineering

Skills

AI-enabled, cybersecurity, digital health, Computer Science, requirements management, executive communication, Coordinate, Leadership, Executive Leadership, accountability, accountable, Biomedical Engineering, partnerships, business objectives, business priorities, PMP, change control, clinical studies, Clinical Leadership, clinical, commercialization, dashboards, design controls, design verification, executive-level communication, executive decision-making, launch planning, governance, innovation, financial, logistics, manufacturing, Marketing, CE Mark, medical devices, metrics, Product Development, full product lifecycle, Product Management, product development process, program lifecycle, Program Management, program management certification, Regulatory Affairs, regulatory approval, ensure compliance, regulatory submission, regulatory submissions, regulatory requirements, risks, risk management, stakeholder management skills, Supply Chain, traceability, Training, usability

Equal Opportunity Employer

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Employer Statement

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Benefits

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

Posting Duration

This posting is open for thirty (30) days.

Fair Chance Policies

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Additional Qualifications

8+ years of Program Management experience in a highly complex regulated medical device environment FDA 510(k) global regulatory experience #randstadengineering