Medical Device Engineer Project Manager

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 to Medical Device Design, Development and Manufacturing projects.

• Must be able to work onsite in Louisville, Kentucky full-time.
• Medical Device Experience Strongly Emphasized including IEC 60601 (Medical electrical equipment safety) and FDA 510K submission.
• Strong emphasis on Customer Facing experience and skills: Negotiation, Project communications, Relationship Management, etc.

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
• Strong technical background
• Strong problem-solving skills
• Technical writing
• Project planning and quoting
• Solid modeling – Solidworks preferred
• Understanding of ISO system requirements
• Strong leadership abilities
• Strong communication skills
• Microsoft Project

Desired Skills:

• Knowledge of mechanical systems and control systems
• PLC and other programming experience
• FMEA analysis preferably COSMOS
• 510(K) submission experience
• Experience with Jira
• Project Management Experience

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 - negotiable based on skills and experience

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