Job Summary:
- 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
- Project Management experience – scope, planning, budgeting, timeline, risk mitigation, reporting, etc.
- 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
- 510(K) submission experience
- Experience with Jira
- Kanban Scrum management approaches
- Project Management Experience
- People Management experience a plus
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
Contact Us:
- Email your resume to hr@occamdesign.com if you are interested!