Collabera · 12 hours ago
Engineering Project Manager – Medical Devices
Collabera is seeking an Engineering Project Manager II to support product development initiatives within an FDA-regulated environment. This role involves leading cross-functional projects, managing timelines and budgets, and ensuring compliance with quality systems and regulatory requirements.
Responsibilities
Lead cross-functional and supplier-facing project teams to execute research and development initiatives within agreed scope, timelines, and budget
Develop and manage project charters, project plans, schedules, resources, and risk assessments throughout the project lifecycle
Drive teams to meet established milestones and deliverables aligned with senior leadership expectations
Plan, lead, and document meetings with internal stakeholders and external suppliers, including distribution of action items and decisions
Manage project documentation, budget tracking, and reporting, including identification of variances and contingency recommendations
Apply problem-solving methodologies to identify issues, assess risks, and support resolution through cross-functional collaboration
Recognize and integrate the broader impact of project decisions on overall product and business outcomes
Prepare and present data-driven reports and presentations to leadership using advanced data analysis tools
Foster a collaborative work environment that supports team effectiveness and accountability
Qualification
Required
Bachelor's degree in Engineering or a related technical discipline
Experience in an FDA-regulated industry supporting product development activities
Strong knowledge of medical device design controls and Quality Management Systems
Familiarity with supplier process validation and applicable quality standards
Experience developing and executing project development plans, including scope, scheduling, and resourcing
Proficiency with data analysis and reporting tools, including spreadsheet and visualization software
Strong written and verbal communication skills with the ability to present to leadership
Preferred
Experience working with external suppliers in a regulated manufacturing environment
Exposure to project risk management and budget forecasting activities
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking/public transportation
Paid time off
Paid sick and safe time
Hours of paid vacation time
Weeks of paid parental leave
Paid holidays annually – as applicable
Company
Collabera
Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.
H1B Sponsorship
Collabera has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (141)
2024 (93)
2023 (120)
2022 (186)
2021 (180)
2020 (146)
Funding
Current Stage
Late StageTotal Funding
$30M2006-05-04Series Unknown· $30M
Recent News
2026-02-06
2024-04-09
2023-01-20
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