Sr. Engineer Manufacturing - Medical Devices

Merz North America•Racine, WI

23h

About The Position

An experienced engineer with a device engineering foundation in a regulated environment heavily focused on manufacturing processes (validation, qualification, process improvements, design transfer, efficiency, supplier management). Ensures process qualification, product reliability, manufacturability, and regulatory compliance are maintained, through cross-functional collaboration, rigorous testing, and continuous process improvement. Able to work with minimal guidance on larger process/product improvements while providing indirect mentorship.

Requirements

Bachelor's Degree Biomedical, Industrial, Manufacturing, Electrical, or Mechanical Engineering.
7+ years Experience in a regulated industry.
3-5 years Experience in manufacturing/support, systems, or sustaining.

Nice To Haves

Master's Degree Biomedical, Industrial, Manufacturing, Electrical, or Mechanical Engineering.
8-10 years experience
Majority experience in healthcare industry specifically with electro-mechanical devices directly managing manufacturing operations.
Experience with ultrasound technologies.
Demonstrated ability to lead projects with large scope and high technical complexity.
Strong technical and problem-solving skills.
Ability to communicate and write effectively.
Emotional self-management in difficult situations.
Understanding and application of of process validation and statistical analysis.
Understanding and application of ISO 13485 quality management system requirements.
Understanding and application of FDA Design Controls and/or EU Medical Device Directive (CE Marking requirements).
Familiar with electro-mechanical manufacturing, depot service, and field service processes and operations.
Experience with system level requirements definition cascading down to process controls.
Experience with system level requirements definition cascading down to process control.
Demonstrated ability to identify and implement process improvements, increase efficiency, cost improvements, and standardization.
Experience with designing and implementing manufacturing, mechanical, or electrical solutions to complex technical problems.
Practical knowledge of Six Sigma methodologies.
Green or Black Belt certification.

Responsibilities

Support production critical manufacturing and supply continuity issues.
Lead and manage complex and critical activities related to maintaining and improving electro-mechanical medical device manufacturing, process optimization, and design via internal and Contract Manufacturing Organizations.
Lead, with minimal oversight, the implementation of manufacturing equipment, process expansions, new initiatives, and process automation. Includes project budgeting, design & interfacing with vendors of equipment and tooling, and maintaining appropriate documentation for new equipment and processes including qualification, verification, and validation.
Lead troubleshooting activities, investigate the root cause to a successful conclusion, and help to resolve manufacturing process related issues, product complaints and CAPA.
Lead and identify improvements in manufacturing equipment/process and product design to improve productivity and quality of current and future products while expecting cost reductions.
Work closely with cross-functional teams, including mechanical and electrical engineers, contract manufacturing organizations, quality, suppliers, and regulatory, to ensure device safety, manufacturability, compliance, compatibility, functionality, and serviceability.
Ensure that device complies with relevant regulations and standards (e.g., FDA, CE Mark, IEC 60601 series, ISO 13485, GMP).
Develop and maintain detailed drawings.
Documentation of design processes and test results.
Execute the Engineering Change Order (ECO) process per Design Controls – Design Change regulations and internal policies.
Support regulatory submissions.
Indirectly mentor junior engineers.
Proactively identify process improvements through proposal of resources, budget, risk, and return on investment.
Perform other duties as needed including review of test. Plans and reports, maintaining project deliverables, and other general engineering related tasks.