At least 5 years
This role is STARs-friendly: Skilled Through Alternative Routes.
37% STARs in role.
Job Description
This role serves as the primary point of contact for the Center for Raw Materials (CRM) team, overseeing CRM task delegation and ensuring strict alignment with established CRM processes. The Technical CRM Project Lead manages day-to-day project work related to change projects, CAPA responses, and material specification updates across a medical device product portfolio, while providing subject matter expertise on materials changes in a regulated environment.
Responsibilities
- Act as the main point of contact for the Center for Raw Materials team and take ownership of CRM task delegation to ensure alignment with CRM processes and procedures.
- Execute the CRM process as defined in applicable procedures and ensure compliance with internal quality and regulatory requirements.
- Ensure thorough follow-through on all CRM-related requests, coordinating actions and closing out tasks as required by the CRM process.
- Lead projects and support project deliverables related to the Center for Raw Materials, including planning, tracking, and reporting on progress.
- Lead and support design change projects, ensuring that changes are properly documented, reviewed, and implemented in accordance with design control requirements.
- Support and oversee CAPA-related activities as they pertain to raw materials and material specifications, ensuring timely and effective resolution.
- Manage and support updates to material specifications for products within the medical device portfolio, ensuring accuracy and regulatory alignment.
- Train and develop incoming CRM team members, providing guidance on CRM processes, tools, and best practices.
- Prepare and present clear, data-driven monthly metrics to stakeholders, summarizing CRM activities, project status, and team performance.
- Ensure timely collection and consolidation of team allocation data for inclusion in monthly metric presentations and reporting.
- Provide subject matter expertise on materials changes, including assessing impact and supporting cross-functional teams with technical insights.
- Continuously explore, propose, and implement opportunities for operational efficiencies in CRM processes, tools, and workflows.
- Collaborate with cross-functional project teams to understand timelines, deliverables, and dependencies, and drive projects to successful completion.
- Direct tasks across the team, assigning responsibilities and monitoring progress to ensure that project milestones and deliverables are met.
- Implement tools or optimize existing workflows to improve project tracking, data collection, and reporting related to CRM activities.
- At least 5+ years of experience with proven technical leadership on projects in a regulated environment.
- Demonstrated ability to lead project teams to defined deliverables, including planning, execution, and completion.
- Strong technical leadership experience on one or more projects, with accountability for outcomes and decisions.
- Proven experience working on cross-functional project teams with an understanding of timelines, deliverables, and interdependencies.
- Bachelor’s degree in Chemistry, Materials Science, Engineering, or a closely related scientific discipline.
- Experience in a medical device, pharmaceutical, or biotechnology regulated industry, including familiarity with FDA-regulated environments.
- Knowledge of design control principles and their application to design change projects.
- Experience with specifications and materials-related documentation within a quality system.
- Understanding of microbiology and CTQ (Critical to Quality) concepts as they relate to materials and product performance.
- Strong project management skills, including planning, prioritization, and coordination of multiple workstreams.
- Ability to collect, analyze, and present metrics clearly to stakeholders.
- Experience directing tasks and coordinating work across team members.
- Strong interdepartmental communication skills, with the ability to collaborate effectively with diverse functional groups.
- Experience implementing tools or optimizing workflows to improve operational efficiency.
- Familiarity with quality principles and good documentation practices (GDP) in a regulated setting.
- Master’s degree in a relevant Engineering or Scientific discipline is a plus.
- Formal project management training or certification such as PMP is preferred.
- Experience working within medical device R&D or life cycle management (LCM) organizations.
- Exposure to or experience with Adaptiv or similar systems and tools used in design control or specification management.
- Experience supporting multiple concurrent projects and balancing competing priorities.
- Ability to translate complex technical and materials-related information into clear, concise documentation and presentations.
- Continuous improvement mindset with a focus on identifying and implementing process enhancements.
This is a hybrid role that combines on-site and remote work, with three days per week on-site and two days remote. The position operates within a highly regulated medical device environment, collaborating closely with R&D, quality, and cross-functional project teams. The work involves regular use of digital project management and documentation tools, as well as systems that support design control, specifications, and metrics tracking. The environment emphasizes collaboration, technical rigor, and continuous improvement, and offers exposure to multiple projects across life cycle management and research and development.
Job Type & Location
This is a Contract position based out of SOMERVILLE, NJ.
Pay and BenefitsThe pay range for this position is $45.00 - $55.00/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)
This is a hybrid position in SOMERVILLE,NJ.
Application DeadlineThis position is anticipated to close on Jun 26, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
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.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
Posting ID: JP-006094927
