Overview

Occam Design (A Division of Creosalus, Inc.) is an innovative leader in the development and manufacturing of the highest quality Class I & Class II medical devices. 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 products and consumer healthcare products. Our capabilities and expertise, coupled with a passion for the work we do, results in on-time and on-budget delivery for our clients.

Our expert engineers, technicians and machinists, coupled with comprehensive manufacturing capabilities, provide innovative and reliable solutions to the most challenging applications. With a world of experience, spread over more than 55 patents and over $3 billion in marketplace sales, clients can trust their product’s design, prototyping, manufacturing and rollout to the team at Occam Design.

We are currently recruiting for a Project Engineering Manager who will be responsible for preparing engineering analysis of projects to include: project scope, preliminary design, life cycle cost, equipment selection, and capital expenditures. 

Duties & Responsibilities

Duties and Responsibilities to include:

*  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 

*  Leads project teams and ensures timely project action items and planning is executed

*  Develops/coordinates RFQ documentation for equipment, services and development projects

*  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 

Qualifications

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 minimum medical related experience

*  3 year minimum as engineering supervisor or manager 

*  Combine 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 

*  Strong 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 Manager Experience

*  People Management experience a plus