Project Manager Engineer

Welcome to Occam Design. Meeting your specs, exceeding your expectations.

• As a Project Manager, you will lead cross-functional teams in the planning, execution, and delivery of complex medical device development projects. You will serve as the main point of contact for clients and internal stakeholders, ensuring projects are completed on time, within scope, and in compliance with industry regulations.

Responsibilities:

• Lead end-to-end project management for medical device development, from early-stage design through manufacturing transfer and launch.
• Serve as primary liaison between clients, engineering, regulatory, quality, and manufacturing teams.
• Develop detailed project plans, timelines, resource allocations, and budgets.
• Monitor and manage project scope, risks, and issues to ensure successful delivery.
• Facilitate regular project status meetings and reports, both internally and with clients.
• Ensure projects adhere to applicable FDA regulations, ISO 13485 standards, and company SOPs.
• Proactively manage change control, risk mitigation, and corrective action processes.
• Support new business opportunities by contributing to project scoping, proposals, and timelines.
• Mentor and coach junior project team members or coordinators, as needed.

Qualifications:

• 5-year commercial Medical Device design, manufacturing or related experience
• 3-year Mechanical Engineer in a design or manufacturing environment
• Combined experience of 5-10 years
• Strong problem-solving skills
• Technical writing
• Solid modeling – Solid Works preferred
• Experience with IEC and ISO Medical Device regulatory requirements
• Intermediate financing/billing skills, intermediate to advanced MS office skills
• Strong personal and team leadership abilities
• Exceptional communication skills
• Microsoft Project
• Work onsite

Preferred Skills:

• Knowledge of mechanical systems and control systems
• PLC and other programming experience
• Knowledge of Medical Device regulatory requirements and processes
• Understanding of technical files
• FMEA analysis preferably COSMOS
• Experience with Jira
• Kanban Scrum management approaches
• Project Management Experience

Educational Requirements:

• BSME or four-year technical degree or equivalent combination of education, training, and experience MBA, or MEM or equivalent combination of education, training and experience

OCCAM Design is ISO 13485:2016 Certified and FDA Registered. As a full-service development firm, OCCAM Design exclusively focuses on medical products and over 30 years of experience developing medical devices, combination products, and consumer healthcare products.

OCCAM Design is an innovative leader in developing and manufacturing the highest quality medical devices. We are located in Louisville, Kentucky. You can contact our team  or via phone at  for more information on working with our team.

Occam Design isISO 13485:2016 Certified and FDA Registered. As a full-service development firm, Occam Design has an exclusive focus on medical products and over 30 years of experience developing medical devices, combination product sand consumer healthcare products.

Occam Design is an innovative leader in the development and manufacturing of the highest quality medical devices.

Our capabilities and expertise, coupled with a passion for the work we do, results in on-time and on-budget delivery for our clients.