Sr Process Development Engineer

Careers that Change Lives

The Medtronic Mission is to Alleviate Pain, Restore Health and Prolong Life. The Sr Process Development Engineer will select, develop, and validate manufacturing systems and processes to produce commercial medical devices, and associated products, that meet quality and cost requirements.  Act under general supervision of Engineering Manager on multiple assignments of complex nature and broad scope.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

GENERAL:

• Partners with Design Engineering to identify Design for Manufacturability and Assembly targets
• Successfully complete all the Process Development Engineering elements of the PDP by the milestone dates
• Be the technical process development lead for a product development team
• Ensure technical assumptions and strategy are correct
• Mentor the team and drive results the right way
• Work with drafting and documentation departments to create all required documents (manufacturing processes, drawings, protocols, reports, etc.)
• Hands-on development of manufacturing processes
• Present status of plans and projects to larger tea

PROCESS DEVELOPMENT:

• Support new product development by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality, cost effective products with optimized yields.
• Pilot Line Development: Design manufacturing sequence of operations/workflow and specifications for equipment/tooling to ensure most efficient and productive layout.
• Feasibility Studies: Perform feasibility studies that explore new process technologies and evaluate its potential for application to catheter manufacturing. Analyze results and make recommendations.
• Equipment and Fixture Development: Identify equipment and fixture needs within pilot line and/or manufacturing operations. Design and develop equipment and fixture requirements and its process parameters where applicable. Work with suppliers and internal stakeholders to realize design and ensure it meets specified requirements.
• Qualification and Validation: Generate and execute plans for equipment qualification and process validation. Develop plans to evaluate process capability. Perform test method development and validation. Apply six sigma methodologies as appropriate.
• Defines and generates all required documentation in support of manufacturing products and processes.  These includes designing and writing engineering protocols in compliance with GMPs and internal procedures, FMECAs, reports, manufacturing instructions and procedures.  Use of appropriate six sigma methodologies such as Design of Experiments (DOEs), Gage R&R, and other statistical tools as necessary.  Provides in depth analysis of issues or problems and implements process improvements to enhance performance of the job area.
• Collaborates with product development teams to support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields.  Communicates with senior internal groups and frequent interaction with external groups (i.e. vendors, suppliers, etc.).
• Develops cost benefit analyses and implements process improvements initiatives to reduce and/or optimize product costs.

SAFETY

• Ensures a safe environment is maintained at all times.
• Leads and supports initiatives to improve safety and compliance to applicable regulations.
• Adherence to company's policies and procedures on maintenance of personnel hygiene and CEA cleanliness ensuring product safety

QUALITY

• Ensures activities performed are in compliance with quality system policies/regulations and Good Manufacturing Practices (GMP) at all times.
• Reports any observed or reported process and/or product non-conformities to Quality and/or management.
• Ensures compliance to training requirements at all times.

PEOPLE LEADERSHIP

• May provide guidance, training and coaching to team members within the job area. 
• May manage projects that require delegation of tasks and review of others' work.

TRAVEL REQUIREMENTS:

May be required to travel up to 5-10%.

• Bachelors degree required
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience

Nice to Have

• Demonstrated strong oral and written communications skills.
• Demonstrated problem solving skills and technical competency.
• Prior knowledge and experience in new product development.
• History of successfully transferring projects to manufacturing.
• Proficient in Microsoft Office.
• Experience in medical device manufacturing or manufacturing in highly regulated industry/environment.
• Prior knowledge and experience in AutoCAD/Solidworks in drafting plant layouts, fixtures, engineering drawings, etc. 
• Demonstrated solid interpersonal skills and ability to work in a team environment.
• Green Belt Certified.
• Project management experience a plus.
• Demonstrated communication skills in presenting information effectively and collaborating with different cross functional groups to achieve work objectives.
• Demonstrated leadership, coaching and interpersonal skills.
• Black Belt Certified a plus.
• Six Sigma training.
• Minitab and Design Expert skills (DOE and other statistical analysis).
• Working knowledge of statistical tools such as DOE, SPC, Hypothesis Testing and Process Capability Studies.
• Stent, balloon, or other medical device catheter manufacturing experience.
• Experience with polymer extrusion, reflow, thermal bonding, and adhesive bonding.
• Familiarity with DMAIC/A3 problem solving approach.
• Understanding of DFSS and DFM activities in the early phase of new product design
• COS conversion knowledge and experience.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)