Summary/Objective:Responsible for leading Supply Chain, Production, and Production Engineering to achieve safety, quality, delivery, cost, and compliance objectives. Provides strategic and technical leadership for manufacturing scale-up, operational excellence, continuous improvement, and new product introduction within a regulated medical device environment.
Essential Duties and Responsibilities[Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualified candidates who need a reasonable accommodation with the application process and/or to perform the essential functions of the position should notify the company's HR contact]
- Directs Supply Chain, Production, and Production Engineering activities in accordance with quality system procedures.
- Leads daily manufacturing operations to ensure products are produced safely, efficiently, on schedule, and in compliance with applicable requirements.
- Develops and executes operational plans to improve quality, throughput, capacity, inventory, and cost performance.
- Provides engineering leadership for manufacturing process development, equipment selection, automation, process validation, and continuous improvement.
- Partners with Design Engineering, Quality, Regulatory, and Program Management to support new product introduction, design transfer, and manufacturing scale-up.
- Oversees production planning, material availability, inventory management, supplier performance, and supply continuity.
- Establishes and monitors key performance indicators for safety, quality, delivery, productivity, inventory, and cost.
- Develops departmental budgets, staffing plans, capital expenditure justifications, and resource recommendations.
- Leads investigations and implementation of corrective and preventive actions related to manufacturing and supplier issues.
- Ensures manufacturing processes remain validated and compliant with applicable medical device regulations, standards, and internal procedures.
- Develops organizational capability through hiring, coaching, performance management, and succession planning.
- Supports internal, customer, and regulatory audits and ensures timely completion of Operations-related corrective actions.
- Establishes and maintains Standard Operating Procedures, work instructions, and forms related to areas of responsibility.
- Works in accordance with quality system procedures.
- Other duties as assigned by Supervisor.
Required Education and Experience- Bachelor's degree in Mechanical, Manufacturing, Electrical Engineering, or a related engineering discipline.
- Minimum of ten (10) years of progressively responsible experience in medical device manufacturing or operations.
- Minimum of five (5) years of leadership experience managing manufacturing operations, supply chain, and/or engineering teams.
- Demonstrated experience with manufacturing engineering, production operations, supply chain management, and quality systems.
- Experience with process validation, equipment qualification, manufacturing scale-up, and design transfer.
- Experience managing budgets, capital projects, resource plans, and operational performance metrics.
Preferred Experience and Qualifications- Experience leading operations in a Class II or Class III medical device environment.
- Working knowledge of FDA Quality System Regulation, ISO 13485, and applicable international medical device requirements.
- Experience with ERP and Manufacturing Execution Systems.
- Experience implementing automation, Lean Manufacturing, Six Sigma, and structured continuous improvement methods.
- Strong analytical and problem-solving skills with the ability to make data-driven decisions.
- Excellent communication skills, including the ability to influence cross-functional teams and represent Operations to internal and external audiences.
- Proven ability to build, develop, and lead high-performing teams.
- Ability to manage multiple priorities in a fast-paced, highly regulated manufacturing environment.
Work Environment and Personal Protective Equipment- This job operates in a professional office environment; many of the job's duties may be performed remotely. This role routinely uses standard office equipment such as computers, phones, photocopiers, and scanners. Personal Protective Equipment may be required for laboratory or field work.
Physical Demands- While performing the duties of this job, the incumbent is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with co-workers.
- This position requires up to twenty percent (20%) travel. Some of the travel is international.
Location- This position is based out of our office in Irvine, California.
Salary Range$170,000 - $230,000
Benefits- Comprehensive medical and dental coverage
- FSA and HSA Plan Options, including an annual company contribution to the HSA
- 401(k) program with employer match
- Generous vacation accrual and paid holiday schedule
