Project Manager - Medical Device Engineer

Occam Design; Louisville (KY); On-site; USD 80,000 - 110,000; Full time

Job summary

Occam Design is seeking a Medical Device Project Manager/Engineer to oversee and contribute to diverse medical device projects. Responsibilities include project management, regulatory compliance, and customer interaction. Candidates should have 2-4 years of relevant experience, with strong technical and interpersonal skills.

Benefits

401(k)

Health insurance

Paid time off

Life insurance

Vision insurance

Flexible spending account

Health savings account

Qualifications

• 2-4 years of Medical Device or related experience.
• 3 years minimum as Mechanical Engineer in a design or manufacturing environment.
• Experience with regulatory requirements: ISO 13485 and IEC 60601.

Responsibilities

• Manage project teams and ensure timely execution of project tasks.
• Negotiate with contractors and suppliers for materials and services.
• Report on progress to the client or senior managers.

Skills

Project Management

Negotiation

Problem-solving

Technical writing

Solid modeling

Leadership

Communication

Education

BSME or four year technical degree

MBA, MEM or equivalent

Tools

SolidWorks

Microsoft Project

Jira

Job description

Project Manager - Medical Device Engineer

Project Manager - Medical Device Engineer

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Occam Design / Thuramed / Project Manager & Consultant / TETRAS Peptide Synthesizer / Talent Acquisition / Medical Device / Bioscience / Pharma /…

Occam Design designs, develops and manufactures Class I, II & III Medical Devices.

Occam Design is searching for a special Medical Device Project Manager/ Engineer to manage and contribute to Medical Device projects.

• Must be able to work onsite in Louisville, Kentucky full-time.
• 2-4 years of Commercial Medical Device Experience is important
• Medical Device Regulatory experience including IEC 60601 (Medical electrical equipment safety), ISO 13485 and FDA 510K submission.
• Project Management experience with emphasis on Customer Facing experience and skills: Negotiation, Project communications, Relationship Management, etc.

Job Duties & Responsibilities

• 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
• 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:

• 2-4 years Medical Device or related experience
• 3 year minimum as Mechanical Engineer in a design or manufacturing environment
• Project Management with customer facing and negotiation skills
• Project planning and quoting
• Strong problem-solving skills
• Technical writing
• Solid modeling – SolidWorks preferred
• Experience with Medical Device regulatory requirements including ISO 13485 and ISO 60601
• Strong leadership abilities and communication skills
• Microsoft Project

Desired Skills:

• Knowledge of mechanical systems and control systems
• PLC and other programming experience
• FMEA analysis preferably COSMOS
• Experience with Jira

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

• 401(k)
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Project Management and Information Technology

• Industries

  Medical Device

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