Director of Hardware & Manufacturing
Direct Report:Vice President of Engineering
Status: Full Time (Regular)
Primary Location: Company Office (Downtown Detroit)
Secondary Location: Wayne State University Research Laboratory (Detroit)
Summary
Seraph Biosciences is seeking a hands-on manufacturing leader with strong design transfer experience in the In Vitro Diagnostic (IVD) industry to help lead hardware and manufacturing in accordance with FDA, ISO, and IEC regulations. The Director will work directly with the VP of Engineering, Advanced Quality Engineer, and a variety of key employees and contractors to lead final design for manufacturing (DFM), process qualification and ongoing production. They will also be responsible for proper design controls throughout Seraph’s product phase gate development process. Finally, the Director will coordinate program management, product development, and talent development/management applicable to both the hardware and disposable aspects of Seraph’s flagship product, Seraspec®.
Responsibilities
• Lead design transfer from gap manufacturer to production manufacturer
• Manage continued design control of the system
• Program management, including all external development partnerships and suppliers, to deliver products to market on time and on budget
• Build and execute strategies with external engineering teams to demonstrate system performance and consistency
• Manage documentation of the product lifecycle from user needs, design inputs, design outputs, design verification, as well as design validation development and execution
• Evaluate supplier capabilities for new product development activities
• Work with quality team to complete risk management activities
• Lead the technical project team through the new product development process
• Lead root cause analysis efforts to quickly resolve any development challenges
• Develop documents along with associated specs to ensure a repeatable manufacturing process
• Travel may be required up to 25% at times
Necessary Qualifications
• Bachelor’s Degree in Engineering with 5+ years of experience in one of the following disciplines: quality, manufacturing engineering, design transfer, production of IVDs, or related fields
• Skilled in DFM and integration of complex IVD systems, including mechanical and electrical systems, firmware, software, and reagents
• Experience developing quality control measures, tools and standards
• Proven experience in design controls, CGMP standards, and working with external development partners
• Direct responsibility with IVD design controls and FDA-regulated products including generating relevant deliverables
• Flexible and collaborative, with a demonstrated ability to lead within a start-up company
• Results driven – demonstrated ability to achieve commitments
• Strong command of the English language and excellent written communication skills
Preferred Qualifications
• Working knowledge of ISO 13485, IEC 14971, IEC 62304, and ISO 61010 standards
• Embedded software system experience
• Experience with Human-factors engineering as it relates to the design process
• Demonstrated program management skills including command of budgeting and timeline tools such as Smartsheet and Microsoft Project
EEO & Employment Eligibility
Seraph Biosciences, Inc. is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Seraph Biosciences, Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Company
Seraph Biosciences was created specifically to commercialize Seraspec®, a Raman spectroscopy-based platform technology for real time pathogen detection and identification at the point of care. Seraspec® represents a paradigm shift away from existing methods for identification of dangerous bacterial, viral, fungal, and parasitic infections. Our patent-pending technology and method of detection effectively eliminates the need for costly and time-consuming laboratory-based methods of specimen collection, processing and pathogen identification.
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Please feel free to send completed applications (resume, cover letter & references) to our company email or via mail at Seraph Biosciences, Inc., 1001 Woodward Avenue, Detroit, Michigan 48226.
Seraph Biosciences, Inc. is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.