Medical Device Engineering Project Manager

OLSA Resources, Inc.; North Carolina; On-site; USD 90,000 - 140,000; Full time

Job summary

A leading medical device company is seeking a Medical Device Engineering Project Manager to oversee projects from inception through implementation. Candidates must have a B.S. in Engineering and 4-8 years of engineering or project management experience in a medical device environment under FDA regulation. Responsibilities include technical support, cost reduction initiatives, and compliance with safety regulations. This is a contract position based in North Carolina with overtime pay for hours over 40.

Qualifications

• 4-8 years experience in engineering/project management or advanced education.
• Strong understanding of regulatory requirements and GMP standards.
• Ability to work in a quality system environment.

Responsibilities

• Manage non-capital and capital projects from inception through implementation.
• Provide technical support to device plants and third-party manufacturers.
• Identify and drive cost reduction projects within Device Operations.
• Ensure compliance with Environmental Health and Safety regulations.

Skills

Project management experience in multi-disciplined environment

Work experience in medical devices under FDA regulation

Proficiency in quality system environments

Quality systems

Cross-functional teamwork

Education

B.S. in Engineering or equivalent

Degree in Materials Science, Electrical or Mechanical Engineering

Electrical Engineering

Mechanical Engineering

Job description

Medical Device Engineering Project Manager

Contract

Candidates applying must have experience with MEDICAL DEVICES

This position is NonExempt. Hours over 40 will be paid at Time and a Half. Engineers who have passed special exams and are certified by the state where site work is specified to be performed, to inspect work and sign off engineering documents. (4-8 years of experience)

Provides support to the company's Nutrition Device Operations group to facilitate efficient operations, optimize existing / develop new processes, and ensure that production goals are met. Product line responsibilities include Enteral Feeding Pumps, Enteral Feeding Tubes, surgical kits, and feeding sets.

Project Management

Manage both non‑capital, and capital projects from inception through implementation, start‑up and ongoing maintenance. Responsibilities include detailed project schedule development, concept and scope development, cost estimation, capital funding requests, budget tracking, conducting project reviews per company Nutrition Design History File requirements and taking product from First Lot to Stock through full‑scale production.

Responsibilities

• Design Engineering - Complete process, mechanical / electrical, and related engineering activities incorporating best available technologies while adhering to Design History File requirements, regulatory requirements, GMP standards, company Engineering Standards and Environmental, Health, and Safety regulations.
• Operations Technical Support - Provide expertise to the device plants, suppliers, Third Party Manufacturers, and QA group to support new product introductions, new process/equipment start‑up, optimizations, vendor qualifications, and process/product alternative evaluations. Implement new and/or current manufacturing methods into manufacturing. Monitor production to determine areas of improvement and react to unforeseen production/manufacturing issues.
• Cost Reduction/Productivity Improvement - Identify and drive cost reduction and productivity improvement projects within Device Operations. Areas of focus include new materials, manufacturing processes, process improvement, new technologies and incorporation of cost‑justified productivity enhancing features in new system designs.
• Environmental Health and Safety (EHS) - Demonstrate accountability and responsibility for Environmental Health and Safety performance and compliance through active participation and support of company's EHS program.

B.S. Engineering or equivalent. Degree in Materials Science, Electrical Engineering, or Mechanical Engineering preferred.

Experience

4-8 years experience in engineering/ project management or advanced education to achieve level of skill.

Skills / Specialized Knowledge

• Project management experience in multi‑disciplined environment required.
• Work experience in medical devices under FDA regulation preferred.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Interfaces with project team members, department managers.
• Quality Assurance, Marketing, Medical, and Regulatory functions.
• May represent department/division on projects or segments of projects.

Job Location