Senior Process Development Engineer

This role is a key part of our team, supporting the design and implementation of manufacturing processes, instrumentation, and equipment - from early R&D through prototypes and full-scale manufacturing. You'll work alongside cross-functional teams to help solve equipment and system challenges and contribute to the development of new processes and technologies that improve product quality and reduce costs.

You'll also play a role in recommending processes for the production of diagnostics products, establishing equipment specifications, and refining manufacturing techniques. Collaboration is central to this position, as you'll work closely with various departments to ensure processes and designs are aligned for smooth new product introductions and future automation opportunities.

We're seeking someone with specialized, in-depth knowledge of manufacturing process design, development, and characterization - including experience identifying and defining critical process parameters and critical quality attributes. This role offers a wide variety of responsibilities, from research and analysis to problem-solving and process improvement.

As a senior-level position, you'll provide guidance in your area of expertise, support department leadership in setting strategic direction, and typically take on broad, complex assignments with a high level of independence. There's also opportunity to mentor consultants and less experienced staff, offering advice and sharing expertise to help grow the team.

Maintaining and continuously improving our quality system is a core part of this role, with a focus on achieving quality objectives through your daily work and decision-making.

The Opportunity:

• Duties are varied and complex often involving research, analysis and solution development.

• Provides direction on issues of area of expertise and assist department leadership in setting strategic direction.

• Support manufacturing operations in troubleshooting equipment and system issues.

• Recommend new process technologies to improve product quality and cost efficiency.

• Establish operating specifications and enhance manufacturing techniques.

• Collaborate with various departments to ensure compatibility of new product technology transfers.

• Develop strategies for future process and equipment automation technology.

• This role may occasionally involve direct, hands-on support of production processes following equipment installation.

Who You Are:

• Bachelor's Degree in Engineering, or a closely related scientific/technical discipline, or equivalent work experience.

• At least 5 years of relevant experience in manufacturing, process/equipment development, R&D/product development, or related experience in an FDA or similarly regulated industry. Advanced technical degree work may be considered.

• Formal training and experience applying FMEA, project management, characterization tools, solid modeling and analysis, mechanical concept design and detailing, process concept development, specification of materials, and vendor management.

• Formal training in biosensor technology or electrochemistry, or significant equivalent work experience.

Skills and Expertise:

• Specialized and in-depth comprehensive knowledge and experience in mechanical equipment design.

• Strong problem-solving skills with the ability to conduct research, analysis, and develop solutions for complex issues.

• Ability to provide strategic direction and expert advice on manufacturing processes.

• Broad knowledge of principles, practices, and procedures in the field of engineering.

• Proven ability to manage complex and difficult assignments with a high degree of originality and ingenuity.

• Capability to mentor and guide consultants and lower-level staff.

Quality Commitment: You will be responsible for maintaining and continuously improving the quality system and achieving quality objectives through your daily activities.

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of Indianapolis, IN is $87,900 - $163,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits