Process Engineer II
A Day in the Life
Be a part of a dynamic team that designs and develops manufacturing processes for new delivery systems from concept through design transfer and product launch. This process development team is committed and driven in our mission to revolutionize the way we manufacture delivery systems while producing a high-quality product for our patients and customers.
The ideal candidate will be a seasoned professional with a passion for advanced manufacturing and the development of manufacturing processes during product development phases. The candidate will be involved with process development, setting up manufacturing operations, and interfacing cross-functionally with other key engineering expertise to develop a product.
In this role, you will part of a team but will be able to work independently with limited supervision to determine and develop approaches to solutions. You will coach and review the work of lower-level professionals. You may manage projects/processes. You will communicate with senior internal and external customers and suppliers. Your work will involve collaboration and dynamic interactions with R&D and Design Assurance regarding products in the development pipeline and with operation team members for new or iterative product implementation. Problems and issues faced are difficult and may require understanding of multiple issues, job areas or specialties.
Responsibilities may include the following and other duties may be assigned:
Process Technologies: Lead the exploration and development of new process technologies that may be incorporated into new product development projects or existing manufacturing lines. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
Process Development: Lead 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. Such activities include, but are not limited to, the following:
Manufacturing Studies: Work with engineering team on studies to characterize process inputs to drive development of critical manufacturing/process specifications that are both robust and meet quality expectations Use appropriate statistical support and Design of Experiments (DOE).
Equipment and Fixture Development: Identify equipment and fixture needs within pilot line and/or manufacturing operations.
Documentation: Generate required documentation in support of manufacturing products and processes. These include engineering protocols/reports, PFMECAs and manufacturing instructions. Ensure compliance with internal procedures, GMP and regulations.
Responsibilities may include the following and other duties may be assigned.
- Provides technical and sustaining engineering support in a manufacturing area.
- Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products.
- Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
- Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
- Interacts with product design and development personnel to ensure that processes and designs are compatible.
- May develop and conduct statistical analysis or recommend additions to document work.
- Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.
- This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.
- Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
- Ensures processes and procedures are in compliance with regulations.
- Bachelors degree required
- Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
Nice to Have
• Previous medical device experience
• Demonstrated problem-solving and critical thinking experience
• Solid oral and written communication skills, including presentation skills
• Solid interpersonal skills and ability to work in a cross-functional team environment
• Solid understanding of statistical techniques and analysis
- Demonstrated computer skills such as Minitab, Excel, Word and Project.
- Process Validation (IQ/OQ/PQ) and Test Method Validation 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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here.
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
