Manufacturing Engineer/ Sr. Engineer-Mechanical

Roche•Indianapolis, IN

25d•Onsite

About The Position

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 Doing now what patients need next. Near Patient Care 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 continuous glucose monitoring. Our aim is to offer innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management. Internal Manufacturing Indianapolis is a function within Roche Diagnostics - Near Patient Care Operations, responsible for the strip manufacturing of the majority of our blood glucose monitoring portfolio for the global demand of our patients. In the future, Internal Manufacturing Indianapolis will also be responsible for sensor manufacturing for our continuous glucose monitoring portfolio. The Opportunity As a Manufacturing Engineer - Mechanical, you will provide technical engineering support of automated and semi-automated manufacturing equipment as required by the production schedule. You will troubleshoot equipment and process issues, lead/contribute to process improvement/characterization projects, train maintenance and production personnel, conduct pilot and validation activities following Roche Diagnostics – Near Patient Care Operations policies and procedure. You will ensure the validated state of the production process/equipment is maintained. Your Responsibilities

Requirements

This position requires hands-on expertise in diagnosing, repairing, and upgrading manufacturing equipment, with a focus on mechanical systems.
Key areas of focus include, but are not limited to:
Mechanical systems: Troubleshooting and improving the performance of mechanical components such as actuators, gearboxes, hydraulics, pneumatics, and other moving parts to ensure reliability and efficiency.
Machine layout and design: Modifying and upgrading existing mechanical systems and equipment layout for better performance and cost-effectiveness.
Equipment performance optimization: Identifying and addressing bottlenecks, wear/lubrication issues, and misalignments to maximize equipment uptime and throughput.
Motion control technologies: Evaluating and improving the operation of motion systems such as servo mechanisms, cam-driven systems, and linear actuators.
Sensor applications: Utilizing sensors to monitor mechanical equipment and processes, including part position, presence/absence detection, and performance monitoring.
Integration with electrical systems: Collaborating with controls engineers to troubleshoot mechanical systems tied to PLCs, motion controls, distributed I/O networks, etc.
GD&T and design for manufacturing
Manage EPL, BOM, and drawing updates
Skilled in working with vendors to identify improvement project solutions and obsolete components replacements.
Experienced in developing and executing equipment qualification requirements, testing, and documentation.
Experienced in collaborating with teams to implement improvements, qualify changes, and resolve quality/downtime issues.
Ability to write and present clear and comprehensive technical documentation.
Highly analytical mind, with exceptional problem-solving skills and attention to detail.
Able to analyze data to identify trends and determine root-cause.
Ability to run simulations and analyze test data.
Ability to design and detail mechanical parts and assemblies for fabrication in Solidworks (or closely related CAD experience).
Superior computer skills
Manufacturing Engineer-Mechanical Bachelor’s degree in Engineering or closely related discipline with 2 years of relevant experience; advanced degree may substitute for previous experience or equivalent experience. Relevant experience is defined as experience from the “Knowledge/Skills/Attributes” section above.
Sr. Manufacturing Engineer-Mechanical Bachelor’s degree in Engineering or closely related discipline with 5 years relevant experience or Master’s of Engineering/PhD with 2 years relevant experience or equivalent experience or equivalent experience. Relevant experience is defined as experience from the “Knowledge/Skills/Attributes” section above.

Nice To Haves

Familiar with GMP in a regulated environment (Medical Device or Pharmaceutical).
Experience troubleshooting controls systems (PLC, Drives, and Vision systems) of high volume/speed manufacturing equipment.
Previous training or experience in Process Improvement Methodologies (e.g. LSS, PDCA, etc.).
Previous experience working in a PLM system
Knowledge of Autocad
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.

Responsibilities

Leads the development, implementation and maintenance of manufacturing methods, procedures and processes in the manufacture of products, components, subassemblies and final assemblies.
Develops and improves mechanical and electromechanical processes by studying 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 production lines.
Manages multiple projects and time scopes for each project.
Ensures process changes are characterized and implemented 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.
Support key initiatives such as information management and life cycle management.