Sr. Mechanical Engineer, Indianapolis

Role:

Our client, an innovative med device company in the north Indianapolis area, is looking for a Sr. Mechanical Engineer to design, develop, and test the mechanical components, equipment, and machinery for an active implantable Class III medical device. This role falls under manufacturing engineering and focuses on developing high-capability manufacturing processes and optimizing product design for manufacturability.

Key Responsibilities

Partner with manufacturing teams to develop, document, implement, and train staff on high-capability manufacturing and testing processes.

Conduct product testing as required.

Create CAD models and prototypes.

Design, source, build, and troubleshoot fixtures and tooling for manufacturing and product development.

Analyze and enhance manufacturing processes for efficiency.

Assess and refine components and subassemblies to improve manufacturability.

Apply industrial research and statistical methods for process control.

Develop engineering protocols, execute plans, collect and analyze data, and produce clear reports.

Implement project management tasks, including goal setting, scheduling, tracking, and reporting.

Ensure compliance with medical device regulations and Quality Management System requirements.

Collaborate with assemblers and technicians to create clear assembly and test procedures while resolving technical issues.

Participate in structured failure analysis and root cause investigations.

Plan and execute qualification studies, including verification and validation processes.

Operate with a high level of autonomy while seeking direction for complex projects.

Work effectively in cross-functional teams.

Qualifications

Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related field.

5-7 years of relevant experience.

Proficiency in fluid systems, especially pumps and related test systems. Microfluidics experience is a plus.

Familiarity with Lean Manufacturing tools and techniques is preferred.

Strong SolidWorks modeling and drafting skills in accordance with ASME Y14.5 standards.

Proficiency with Microsoft 365 tools.

Strong oral and written communication skills.

Experience working within medical device regulations (ISO 13485, ISO 14971, FDA 21 CFR 820) and adherence to Quality Management System requirements.