Overview
On Site
USD 80.00 - 90.00 per hour
Full Time
Skills
Electrical Engineering
Research and Development
Computer Hardware
Manufacturing
Design Controls
ISO 13485
Business Systems Interface
EMEA
Regulatory Compliance
Project Planning
Budget
Mentorship
Recruiting
Mechanical Engineering
Medical Devices
Program Management
Taxes
Life Insurance
SEP
Partnership
Collaboration
Business Transformation
Law
Job Details
Long term contract
Onsite Alameda or Milpitas, CA
Top Skills Details
Role:
Background:
Company manufactures a Continuous Glucose Monitor (CGM) device for people with Type One and Type Two Diabetes.
Hiring a Program Manager as part of the R&D Hardware Team who will be involved in material obsolescence for their CGM device. Due to a change in regulations, the company is needing to make updates to its global manufacturing processes.
The work requires a background in medical device development, design, control, regulations (QSR, ISO 13485, BSI, FDA, etc.), and processes.
This Program Manager will be focused on regulatory change for their different regions including North America, Latin America, EMEA, APAC and will be focused on how regulatory change impacts the products and what new actions need to be taken to drive project compliance for their different markets.
Description of work to be performed:
Responsibilities:
Design, communicate, and implement an operational plan for completing a project; monitor progress and performance against the project plan; resolve operational problems, minimize delays.
Identify, develop, and gather necessary resources to complete the project.
Prepare designs and work specifications; develop schedules, budgets and forecasts; select materials, equipment, project staff, and contractors.
Estimate costs, resources, and time required to complete.
Monitor activities, allocate resources, and assign tasks to ensure targets are met.
Liaise with other areas in the organization to secure specialized resources and contributions for the project.
Conduct project meetings and prepare reports to communicate the status of the project within and beyond the project team.
Coach and mentor project staff and assist them to solve problems.
Additional Skills & Qualifications
Hiring manager is open to a variety of profiles. He doesn't have one type of candidate he is looking for. He found a few systems engineers and mechanical engineers that had medical device experience and some project/program management experience that he believed could do the role. He also believes a true program/project manager with med device experience could do the role too.
Pay and Benefits
The pay range for this position is $80.00 - $90.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Alameda,CA.
Application Deadline
This position is anticipated to close on Sep 26, 2025.
>About TEKsystems:
We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
About TEKsystems and TEKsystems Global Services
We're a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We're a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We're strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We're building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Onsite Alameda or Milpitas, CA
Top Skills Details
- EE/ME preferred but other engineering degrees will be considered background
- Experience with Medical Device development life cycle & Understanding of Medical Device regulations such as QSR, ISO 13485, BSI, FDA
- 10+ years Project and Program Management combined experience in medical device; minimum 7+ years Program Management experience
- 4 years medical device experience as a PgM
- Experience w/ Global Manufacturing (incl US, Mexico, UK) for labels, plastic molds and components including Design Transfer and Manufacturing Transfer experience for labeling, molds, plastic components, electrical components
Role:
Background:
Company manufactures a Continuous Glucose Monitor (CGM) device for people with Type One and Type Two Diabetes.
Hiring a Program Manager as part of the R&D Hardware Team who will be involved in material obsolescence for their CGM device. Due to a change in regulations, the company is needing to make updates to its global manufacturing processes.
The work requires a background in medical device development, design, control, regulations (QSR, ISO 13485, BSI, FDA, etc.), and processes.
This Program Manager will be focused on regulatory change for their different regions including North America, Latin America, EMEA, APAC and will be focused on how regulatory change impacts the products and what new actions need to be taken to drive project compliance for their different markets.
Description of work to be performed:
Responsibilities:
Design, communicate, and implement an operational plan for completing a project; monitor progress and performance against the project plan; resolve operational problems, minimize delays.
Identify, develop, and gather necessary resources to complete the project.
Prepare designs and work specifications; develop schedules, budgets and forecasts; select materials, equipment, project staff, and contractors.
Estimate costs, resources, and time required to complete.
Monitor activities, allocate resources, and assign tasks to ensure targets are met.
Liaise with other areas in the organization to secure specialized resources and contributions for the project.
Conduct project meetings and prepare reports to communicate the status of the project within and beyond the project team.
Coach and mentor project staff and assist them to solve problems.
Additional Skills & Qualifications
Hiring manager is open to a variety of profiles. He doesn't have one type of candidate he is looking for. He found a few systems engineers and mechanical engineers that had medical device experience and some project/program management experience that he believed could do the role. He also believes a true program/project manager with med device experience could do the role too.
Pay and Benefits
The pay range for this position is $80.00 - $90.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Alameda,CA.
Application Deadline
This position is anticipated to close on Sep 26, 2025.
>About TEKsystems:
We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
About TEKsystems and TEKsystems Global Services
We're a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We're a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We're strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We're building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.