Occam Design (A Division of CreoSalus, Inc.) is a leader in the Design, Development and Manufacturing of Class I, II & III medical devices.
Occam Design is searching for a unique Medical Device Mechanical Engineer /Project Manager to manage and contribute toMedical Device Design, Development and Manufacturing projects.
- Medical Device Experience Strongly Emphasized including IEC 60601 (Medical electrical equipment safety) and FDA 510K submission.
Job Duties & Responsibilities
- Life cycle cost and equipment selection
- Work with management and clients to understand project vision
- Estimating the timescales, costs and resources needed
- Selecting and leading a project team
- Negotiating with contractors and suppliers for materials and services
- Reporting regularly on progress to the client or to senior managers
- Responsible for scope, schedule, and budget on multiple concurrent capital projects
- Develops scopes for project funding
- Maintains Development and Capital Expenditure list and on-going Budget Planning
- Leads design reviews on projects
- Manages project teams and ensures timely project action items and planning is executed
- Develops/coordinates RFQ documentation for equipment, services and development projects
- Quality Control - Assure compliance with quality policies and procedures related to project execution activities
- Review and approval of technical documents and reports such as protocols, SOPs, and cGMP documents
- Lead risk assessment exercises related to equipment and processes (FMEA, VSM, etc)
- Basic understanding of controls technology and related regulations
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
Experience/Skills Requirements:
- 5 year Medical Device or related experience
- 3 year minimum as Mechanical Engineer in a design or manufacturing environment
- Combined experience of at least 10 years
- Supervisory and related people skills
- Strong technical background
- Strong problem-solving skills
- Technical writing
- Project planning and quoting
- Solid modeling – Solidworks preferred
- Understanding of ISO system requirements
- Intermediate financing/billing skills, intermediate to advanced MS office skills
- Strong leadership abilities
- Strong communication skills
- Adequate knowledge of Microsoft Project
Desired Skills:
- Knowledge of mechanical systems
- Knowledge of control systems
- PLC and other programming experience
- Knowledge of regulatory requirements and processes
- Understanding of technical files
- FMEA analysis preferably COSMOS
- Some regulatory experience
- 510(K) submission experience
- Experience with Jira
- Kanban Scrum management approaches
- Project Management Experience
- People Management experience a plus
Equal Employment Opportunity
It is our policy to provide equal employment opportunities without regard to race, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability or protected veteran status. We believe that these opportunities should be available on the basis of individual merit, and we encourage applicants and employees to strive for advancement on this basis.
EOE AA M/F/Vet/Disability
Job Type: Full-time
Pay: $80,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: In person