Research and Development Process Development Manager

Posting Date 1 month ago(4/29/2021 3:02 PM)
Requisition ID
2021-8914
Job Location(s)
Bloomington IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Medical Holdings
Category
Engineering

Overview

The Process Development Manager at Cook Medical is responsible for leading an engineering team designing and optimizing processes required to manufacture new medical devices. This includes providing technical direction and leadership for teams designing the manufacturing processes, line lay-out, and equipment for Vascular Division R&D projects manufactured primarily at the Bloomington manufacturing sites. Product lines/Projects could include angiographic catheters, endovascular stents, implant delivery systems, and abscess drainage catheters.

Responsibilities

• Lead team designing and implementing and equipment for new products
• Train and mentor team members about the methods needed for efficient and effective process development (design for manufacturing, process validation, process capability, lean manufacturing, equipment selection and specification development)
• Ability to design and optimize process and process equipment for large and small scale manufacturing
• Collaborate with Product Design Teams, Operations, NPI and Production Engineering to ensure effective completion of all activities associated with project objectives
• Monitor and report project progress, delays, and completions
• Manage team resource allocation and provide estimates for future projects
• Provide direct and frequent positive and constructive feedback on performance and improvement areas for team members
• Identify and communicate to management on areas for improvement in both systems and personnel (training and developmental needs)

• Review and approve team member documentation (PFMEA’s, Production Instructions, Drawings etc.) and expense reports
• Must have effective oral, written and presentation communication skills, with the ability to organize information on manufacturing line development to facilitate cross functional decision making
• Ability to design and optimize process and process equipment for large and small scale manufacturing
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Must show leadership skills to mentor and represent the organization in an exemplary manner in knowledge, ethics and behavior
• Ensure that a risk based approach is applied during the development implementation and validation of all processes

Qualifications

• Bachelor's degree in Engineering, or related field is required
• Minimum 5yrs, experience in Class II/III medical device manufacturing
• Minimum 10yrs, experience in manufacturing line design, preferred
• Experience designing and optimizing process and process equipment for large and small scale manufacturing
• Strong knowledge of designing production lines and equipment in the medical device industry

• Strong knowledge of process validation, design for manufacturing, statistics and lean manufacturing principles
• Strong knowledge of medical device quality standards ISO13485/FDA 21 CFR 820 and similar regulated industry standards
• Project and team management experience, is preferred
• Proficient in Microsoft application (Outlook, Word, Excel, Project)

 

Physical Requirements:

• Works under general office environmental conditions
• Sitting for extended periods, utilizes close visual acuity for working with computers
• Frequently required to stand; walk; use hands to grasp, feel or touch; reach with hands and arms
• Occasionally lifts and/or moves more than 20 pounds

• Ability to travel over-night up to 10 % of the time, if needed
• Personal protective equipment including safety glasses, lab coat and gloves required in many areas associated with this position

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