In this role, you’ll be an important part of designing and implementing manufacturing processes, instrumentation, and equipment — supporting projects from early R&D and prototypes all the way through plant and manufacturing scale-up. You’ll bring your expertise in engineering, mechanical equipment design, and process development to help our teams solve problems, optimize systems, and continuously improve how we make our products. This position offers the chance to develop and recommend new process technologies aimed at improving product quality and reducing costs. You’ll help establish operating equipment specifications, refine manufacturing techniques, and play a key role in recommending processes for the production of diagnostics products. Collaboration is essential, as you’ll work alongside teams from across the organization to ensure processes and designs are aligned and compatible for new product introductions and future automation initiatives. We’re looking for someone with deep, specialized knowledge in mechanical equipment design who enjoys tackling a variety of complex challenges. This role often involves research, analysis, and creative problem-solving, with opportunities to provide strategic direction in your area of expertise and contribute to broader departmental priorities. As a senior-level position, you’ll typically handle complex, wide-ranging assignments with considerable independence. You’ll also have the chance to mentor and guide less experienced staff and consultants, sharing your knowledge and expertise to help them grow. A strong commitment to maintaining and continuously improving our quality system is essential, with a focus on achieving quality objectives through your daily work and decisions. 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. Occasional travel (up to 15%) may be required to support equipment development, installation, and commissioning activities. 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. 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.
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