Sr. Manager, OEM Process Engineering

Job Overview

Manages team of Process Engineers to manufacture medical device finished goods and components for customers. Leads the cross functional team to develop the processes, procure equipment, and set up production lines to deliver product according to customer specifications.

This work includes generation of protocols, hands on work with equipment, and working with manufacturing operations to align build schedules.  In addition, the incumbent must be able to think through issues and troubleshoot problems related to medical device manufacturing, work with investigations teams to provide robust root causes, technical justifications, understanding changes to equipment and processes, and interact with quality and regulatory departments to help guide decision making. The incumbent will be expected to develop overall validation strategies for specific projects.

At a minimum, the person should be able to execute work independently, work with various groups across the organization, be a self-starter, and be able to oversee and lead projects and personnel.  The managers goals are to ensure that all projects which support products that are manufactured on behalf of other legal manufacturers are running as intended, that processes are appropriately validated, that processes transferred to operations are robust, and that the team is always looking for areas of improvement.

Job Responsibilities and Essential Duties

• Develop, manage, and support a team of technically skilled engineers and technicians who share the job duties and responsibilities noted below.
• Process verification and validation activities related to the manufacture of medical device products as well as updates/optimizations to existing commercial products.
• Defining Process Verification and Validation strategies for process improvements, changes, and new process development efforts.
• Facilitate all new manufacturing on behalf of customers which are legal manufacturers.
• Achieve manufacturing objectives as specified by the management team by promoting investigation, inventiveness, creativity and solutions to various process, implementation, and material flow/control problems.
• Generating and executing protocols and writing final reports.
• Project management of overall and individual projects and activities.
• Work to implement a culture of Right-First Time and continuous improvement relative to process procedures and systems.
• Perform and guide nonconformance root cause investigations, gap analyses, process risk assessments, assessment of change controls for process impact.
• Provide expertise to Manufacturing Operations, QA, QC, etc. for trouble-shooting and resolution of process issues as needed.
• Ability to execute and manage multiple projects and activities of extreme complexity simultaneously.
• The position requires good communication skills to keep customers, peers, direct reports, area management, and site leadership up-to-date with progress of all projects in order to ensure projects are completed in a timely manner and on schedule.
• Be able to work well and interact with cross functional teams that include personnel from Manufacturing Operations, Planning, Quality Engineering, Quality Control, Operations, Regulatory Affairs and Customers.
• Maintain compliance with all regulatory standards for product and personnel safety.
• Generation of supporting documents for Quality and Regulatory audits and submission as required.
• Support regulatory inspections through the preparation, defense and interaction with auditors.
• Ensures through monitoring of individual assignments that cross-training is on-going. Develops the leadership of the unit through mentoring, formal and informal training programs.
• Communicate new ideas, technology advances, and opportunities to management team for review, evaluation and action.
• Assist in identifying the yearly department's needs and helping support it through the budgeting process.
• Create and maintain a safe environment. Ensure legal requirements and safety policies are enforced.
• Assists in special projects as needed.
• Contributes to team effort by accomplishing related duties as requested.

Minimum Requirements

• Bachelor's Degree in Engineering, Industrial Management, or related field, or equivalent.
• Minimum seven years of demonstrated leadership experience within a medical device manufacturing or process development environment.
• Minimum of two years of demonstrated direct management of other engineers, technicians, and/or other technical personnel.

Required Knowledge, Skills and Abilities

• Ability to work with flexible and changing production schedules.
• Self-motivated and have the ability to manage projects, personnel, and problem solve on a regular basis.
• Highly organized with strong project management and technical abilities.
• Demonstrated ability to develop strategies that will help build a positive process engineering and manufacturing operations environment.
• Strong computer skills, including MS Office applications (Word/Excel) are required.

Supervision/Management Of Others:

• Supervises Engineers and Technicians.

Internal and External Contacts/Relationships

• Interacts with internal cross functional teams that include personnel from Manufacturing Operations, Planning, Quality Engineering, Quality Control, Operations, Product Development, and Regulatory Affairs.
• Interacts with external suppliers, vendors, equipment manufacturers, customers etc. 

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
• Office and clean room production environment
• May work extended hours during peak business cycles.