Manufacturing Engineer - Controls

Roche; Indianapolis (IN); On-site; USD 70,000 - 130,000; Full time

Job summary

Roche Diagnostics Indianapolis is seeking a Manufacturing Engineer - Controls to lead continuous improvement on automated equipment that makes our blood glucose monitoring products. You will analyze data, design validation activities, and ensure compliance with Roche standards while supporting operators and technicians.

Located in Indianapolis, IN, this role blends project leadership with hands-on problem solving, requiring a Bachelor’s degree in Engineering and experience with manufacturing

Qualifications

• Bachelor’s degree in Engineering or related field with 2 years of related experience.
• Experience troubleshooting controls systems in high-volume manufacturing.
• Familiar with GMP in regulated environment (Medical Device or Pharmaceutical).

Responsibilities

• Leads the development, implementation and maintenance of manufacturing methods, procedures and processes in the manufacture of products, components, subassemblies and final assemblies
• Develops mechanical and electromechanical processes by studying customer requirements; researching and testing manufacturing and assembly methods and materials; and soliciting observations from operators and maintenance technicians
• Interfaces with design and process development engineering in coordinating the release of new products to the manufacturing process.
• Helps to estimate manufacturing cost and makes recommendations for tooling and process requirements of new or existing lines
• Manages multiple projects and time scopes for each project
• Ensures process changes are characterized and implements following validation policies and procedures
• Assures system and product quality by designing testing methods; testing finished-product and system capabilities; and confirming fabrication, assembly, and installation processes
• Assists department leadership in setting strategic direction
• Possesses and applies a broad knowledge of principles, practices, and procedures of the field
• Maintains product and company reputation by complying with government regulations
• Provide guidance and advice to lower level staff
• Participates in the on call rotation to provide off shift / weekend support to production, as needed

Skills

Data analysis

Technical documentation

Communication

Analytical thinking

Problem solving

Education

Bachelor's degree in Engineering

Tools

RSLogix 5000/Studio 5000

FactoryTalk View ME/SE

Cognex Insight Explorer

Distributed IO

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Who We Are

Doing now what patients need next. A pioneer in the development of blood glucose monitoring and insulin delivery systems, Roche Diabetes Care (RDC) is committed to helping people with diabetes everywhere in the world think less about their daily diabetes routine, so they can get true relief, day and night. We offer a broad portfolio of solutions for both people with diabetes and their professionals - from blood glucose monitoring to information management to insulin delivery to continuous glucose monitoring. Our aim is to offer innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management.

We are strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.

At Roche, we are passionate about transforming patients’ lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

Internal Manufacturing Indianapolis is a function within Roche Diabetes Care Global Operations & Quality, responsible for the manufacturing of the majority of our Diabetes Care portfolio for the global demand of our patients.

Role Purpose

Join our Equipment Performance team at Roche Diagnostics, Indianapolis, as a Manufacturing Engineer - Controls. In this role, you'll lead continuous improvement initiatives on the automated equipment that manufactures our blood glucose monitoring (BGM) strips and our emerging continuous glucose monitoring (CGM) devices. You'll dig into the data, identify optimization opportunities, and drive projects that directly improve how our equipment performs. You'll also design and execute validation activities to keep our processes aligned with Roche's rigorous compliance and regulatory standards.

Beyond these improvement projects, you'll be the technical expert our operators and technicians turn to for support and troubleshooting, building relationships and solving real problems that keep our lines running smoothly. It's the perfect blend of strategic project work and hands-on collaboration that makes the role deeply rewarding.

Your Responsibilities

• Leads the development, implementation and maintenance of manufacturing methods, procedures and processes in the manufacture of products, components, subassemblies and final assemblies
• Develops mechanical and electromechanical processes by studying customer requirements; researching and testing manufacturing and assembly methods and materials; and soliciting observations from operators and maintenance technicians
• Interfaces with design and process development engineering in coordinating the release of new products to the manufacturing process.
• Helps to estimate manufacturing cost and makes recommendations for tooling and process requirements of new or existing lines
• Manages multiple projects and time scopes for each project
• Ensures process changes are characterized and implements following validation policies and procedures
• Assures system and product quality by designing testing methods; testing finished-product and system capabilities; and confirming fabrication, assembly, and installation processes
• Assists department leadership in setting strategic direction
• Possess and apply a broad knowledge of principles, practices, and procedures of the field
• Maintains product and company reputation by complying with government regulations
• Provide guidance and advice to lower level staff
• Participates in the on call rotation to provide off shift / weekend support to production, as needed

Knowledge/Skills/Attributes

• Ability to run simulations and analyze test/equipment data
• Ability to write and present clear and comprehensive technical documentation
• Communicates effectively with People Leaders and stakeholders
• Highly analytical mind, with exceptional problem-solving skills and attention to detail
• Superior computer skills, with the following controls experience preferred:
  • RSLogix 5000/Studio 5000 programming experience (ladder, structured text, SFC, AOI)
  • FactoryTalk View ME/SE programming experience
  • Cognex Insight Explorer programming
  • Distributed IO (Profibus/Ethernet IP)

Who You Are

• Bachelor’s degree in Engineering or closely related discipline with 2 years of related experience; advanced degree may substitute for previous experience.

Preferred

• Previous experience troubleshooting controls systems of high-volume/speed manufacturing equipment
• Familiar with GMP in a regulated environment (Medical Device or Pharmaceutical)
• Previous training or experience in Process Improvement Methodologies (e.g. LSS, PDCA, etc.)
• Demonstrates excellent interpersonal, communication, and teamwork skills
• Strong ability to teach and educate key stakeholders and other colleagues
• Deep commitment to cross-functional collaboration and breaking down silos to achieve the best results for the organization

The expected salary range for this position based on the primary location of Indiana Base Pay Range $70,100 - $130,100 Annual. Actual pay will be determined based on experience, qualifications and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance, as well as participation in a long-term incentive program. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Location: This position is based in Indianapolis, IN

Relocation: Relocation benefits are not available for this posting

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.