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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading operations for new product development, including manufacturing strategy execution, cross-functional collaboration, and compliance with regulatory requirements. Proven ability to manage project metrics and drive process development in regulated industries.
Highest-signal resume keywords
Manufacturing Strategy DevelopmentCross-Functional Project LeadershipRegulatory Compliance ExperienceProcess Development ExpertiseStakeholder Influence
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Manufacturing EngineeringProduct DevelopmentDesign Transfer ActivitiesCapacity PlanningOperational Readiness MeasuresProcess ValidationEquipment SelectionBudget ManagementContract Manufacturer EngagementProduct Commercialization
Soft Skills
Influencing StakeholdersDriving ExecutionCollaboration
Industry Keywords
Regulated IndustriesOperational Excellence MethodologiesSupply Chain ManagementQuality RequirementsCross-Functional Teams
About the role
Key responsibilities & impact- Lead Operations activities for new product development programs as the primary Operations representative on cross-functional core teams
- Develop and execute manufacturing strategies, including site selection, capacity planning, capital planning, and contract manufacturer engagement
- Direct extended Operations teams to deliver program milestones, budgets, and launch readiness objectives
- Manage Operations project metrics, including predicted product cost, manufacturing yield, and operational readiness measures
- Develop design transfer plans, reports, and documentation required for product commercialization
- Drive manufacturing process development, validation planning, equipment selection, and scale-up activities
- Align Supply Management, Manufacturing Engineering, Packaging, Sterilization, Distribution, and Supply Chain functions to program objectives
- Ensure compliance with new product development processes, regulatory requirements, and operational excellence methodologies
- Partner with Product Development, Supply Chain, Manufacturing, Quality, and external manufacturing partners to establish and execute operations strategies supporting product commercialization
Requirements
What you’ll need- Bachelor's degree with 5+ years of engineering experience in manufacturing and/or product development OR advanced degree with 3+ years of engineering experience in manufacturing and/or product development
- Experience leading cross-functional projects or programs within product development or manufacturing environments
- Experience developing and implementing manufacturing strategies, process development, or design transfer activities
- Experience working in regulated industries with documented process and quality requirements
- Experience influencing stakeholders and driving execution across multiple functions
- For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment
- Ability to travel domestically and internationally up to 25% based on program needs
Benefits
Comp & perks- Competitive salary and flexible Benefits Package
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps global well-being program
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement
- Capital Accumulation Plan for eligible employees
- Temporary employees eligible for paid sick time as required by applicable state law
- Employee Stock Purchase Plan for temporary employees
- Reasonable accommodations for qualified individuals with disabilities
