Johnson & Johnson Careers

Senior Process Engineer

Plymouth, Minnesota
Process Engineering


Job Description

Requisition ID: 8304180406

Sterilmed is currently recruiting for a Senior Process Engineer to be located in Plymouth, Minnesota.

 

The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.

 

Sterilmed is an FDA-registered medical device manufacturer that provides solutions for hospitals faced with the challenge of improving environmental sustainability and reducing costs without compromising patient care. We are proud to be a part of keeping healthcare accessible and affordable for all by offering services that support device recycling and reprocessed products that deliver cost savings for our customers.

 

           

Position Summary:

The senior engineer is responsible for new product transition from R&D into production through close cooperation with synergy Health, as well as continuously improving existing products to improve quality, reduce cost and drive incremental revenue.  The professional ability to challenge the existing paradigms with innovative solutions to improve business results is a must.  

 

 

  • Lead engineer for new product transition from R&D into production. Support assigned NPD projects.
  • Develops plans to evaluate process repeatability and stability through equipment qualification and process validation.
  • Designs, develops, and implements basic manufacturing equipment, fixturing and tooling.
  • Generates all required documentation in support of the development and manufacturing products and processes, including timelines, responsibilities, IQ, OQ, PQ protocols/reports.
  • Collaborate with team members and formulate cross-functional teams to optimize the operation of equipment through the implementation of optimal run settings, line balancing, preventative and predictive maintenance plans and process analysis
  • Works with outsourced partners to develop metrics such as labor time, yields, statistical analysis, qualification and validation of process, tooling and equipment.
  •  
  • Provides support in the resolution of product complaints and/or safety issues.
  • Works with various departments to facilitate pilot production of new products.
  • Collaborate with Operations on subjects pertaining to the improvement standards, Capital Expenditure standards, audits, 5S initiatives, failure analysis, results management, QIS, FMEA, Six Sigma & other process improvement methodologies.
  • Solid understanding of modern manufacturing processes including but not limited to manufacturing assembly processes, cleaning process.
  • Partnering with outsourced partner to Implement sustaining projects in a variety of Lean Manufacturing, Six Sigma or Continuous Improvement Methodologies including but not limited to One Piece Flow, Visual Management, Facilitation of Kaizen Events, Kanban and 5-S.
  • Develop & implement new processes as well as adjusting existing standards, structures, systems, & equipment.
  • Serve as project manager of a multifunctional team to drive new product development activities from concept to launch.
  • Develop and confirm methods for reprocessing of assigned devices
  • Write verification and validation documentation and conduct required testing as needed
  • Familiar with all aspects of medical device product development, including design, verification and validation, FDA submission, and design transfer into manufacturing.
  • Perform reverse engineering to identify functional and performance requirements for reprocessed devices
  • Design and build new components and assembly tooling
  • Perform testing and inspection functions including forensics and root cause analysis
  • Assist regulatory compliance efforts and verification and documentation related to engineering standards
  • Author, revise, train, and provide support for production work instructions.
  • Identify new processing needs and perform continuous improvement to support sustaining efforts
  • Perform reverse engineering to identify functional and performance requirements for reprocessed devices
  • Lead and facilitate process improvement activities
  • Role may include project and team management responsibilities
  • Committed to building a positive culture
  • Other responsibilities may be assigned & not all responsibilities listed may be assigned
  • Prior catheter device and project management experience desired.

 

 


Qualifications

Education, Skills, & Experience Needed to Perform Position Function:

  • Bachelor degree in Chemical, Mechanical, Electrical Engineering or equivalent experience
  • Minimum of experience in the medical device industry
  • Prior experience in the medical device industry is preferred
  • Proficient in Microsoft Office  
  • Strong statistical skills and knowledge of statistical software
  • Experience with DOE, FMEA, GMP, and QSR
  • Solidworks knowledge preferred
  • Ability to work within an ISO structured quality system
  • Knowledge of engineered materials and fabrication methods
  • Good planning, multi-tasking, and project management skills
  • Demonstrated track record of completing projects on time and accomplishing goals
  • Ability to function independently as well as part of a team
  • Excellent written and oral communication skills
  • Ability to manage multiple priorities in fast-paced environment

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

 



Primary Location
United States-Minnesota-Plymouth
Organization
Sterilmed, Inc. (6215)
Job Function
Process Engineering
Requisition ID
8304180406