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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading cross-functional operations teams to achieve product development and commercialization objectives, with a strong focus on project management, manufacturing strategies, and regulatory compliance in the medical device industry.
Highest-signal resume keywords
Cross-Functional Project LeadershipManufacturing Process ValidationDesign Transfer ActivitiesLean ManufacturingPMP Certification
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementManufacturing ReadinessSupply Chain StrategyCapacity PlanningRisk ManagementPerformance MetricsDesign for ReliabilityDesign for ManufacturabilityDesign for Six SigmaQuality Management Systems
Soft Skills
Stakeholder InfluenceTeam Leadership
Certifications & Qualifications
PMP Certification
Industry Keywords
Medical Device RegulationsDesign History FilesCommercialization RequirementsNew Product IntroductionCore Team Operations Representative
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Lead cross-functional Operations teams to deliver new product introduction milestones, manufacturing readiness, and commercialization objectives
- Represent Operations as the primary interface to product development core teams
- Ensure operational requirements are incorporated into program decisions
- Develop and manage operations project plans, timelines, budgets, dependencies, risks, and performance metrics
- Define manufacturing and supply chain strategies, including site selection, make-versus-buy decisions, capacity planning, contract manufacturing scope, and business continuity
- Drive design transfer activities, manufacturing scale-up plans, validation strategies, and operational deliverables for product launch
- Coordinate development and launch builds across manufacturing value streams
- Monitor schedule performance, yield targets, and operational risks
- Ensure compliance with quality system requirements, design history documentation, and regulatory submission support
- Apply Design for Reliability, Design for Manufacturability, Lean Manufacturing, Design for Six Sigma, and related methodologies
Requirements
What you’ll need- Bachelor's degree with 7+ years of engineering, operations, manufacturing, supply chain, or program management experience OR Master's degree with 5+ years of engineering, operations, manufacturing, supply chain, or program management experience
- Experience leading cross-functional projects involving product development, manufacturing transfer, or new product introduction
- Experience managing project schedules, risks, budgets, and operational performance metrics
- Experience working within regulated industries and quality management systems
- Experience influencing stakeholders and leading matrixed teams without direct authority
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 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
- Preferred: Experience serving as a Core Team Operations Representative (CTOR) or operations lead for medical device product development programs
- Preferred: Experience with manufacturing process validation, capacity planning, and design transfer activities
- Preferred: Experience applying DFSS, Lean Manufacturing, DFMA, or Reliability Engineering methodologies
- Preferred: Knowledge of medical device regulations, Design History Files, and commercialization requirements
- Preferred: PMP certification and/or advanced degree
Benefits
Comp & perks- Competitive salary and flexible benefits package
- Health insurance
- Dental insurance
- 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
- Paid sick time for temporary employees as required by applicable state law
