Job Description:

The Director of  Process Engineering will be responsible for the manufacturing engineering for a novel diagnostic platform. The primary responsibility is to lead process development efforts in a broad range of areas including instruments, injection molded disposables, reagents, assay kits, and product packaging. The role will begin in product development and will transition to a manufacturing and operations role as the product reaches commercialization. The successful candidate must possess advanced knowledge in device manufacturing and have experience driving the completion of projects of high complexity, ideally in FDA regulated environments. To succeed, the candidate must have well developed leadership qualities and exhibit creativity, foresight, and mature judgment. The candidate must have excellent organizational skills, including the ability to evaluate, prioritize, and handle multiple subprojects and priorities. The candidate must have a hands-on approach, including getting in the lab to troubleshoot and assist as may be needed.

Summary/Objective:

Essential Functions:

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Lead the process development and manufacturing activities to enable pilot and high-volume manufacturing of Sherlock’s products.
• Collaborate with OEM partners to transfer designs to pilot and full-scale manufacture.
• Manage and drive the bill of materials to low-cost solutions design and automation choices.
• Develop pilot scale processes for cartridge assembly and lyophilized reagents.
• Develop product packaging designs and specifications
• Build and deliver an iterative series of alpha and beta prototypes.
• Implement and manage drawing and BOM revision tracking
• Anticipate potential problems that may impact cost and performance and drive the development and implementation of risk mitigation plans.
• Lead identification of solutions to complex technical issues by root cause analysis procedure and propose potential manufacturing or design modifications.

Competencies:

• Communicate with Impact
• Decision Making & Problem Solving
• Taking Initiative and Follow-up
• Planning and Organizing
• Project Management
• Building Effective Partnerships
• Team Building
• Business Acumen
• Adaptability
• Coaching & Development
• Change Leadership
• Technical Skills/Professional Knowledge

 Supervisory Responsibilities:

• Yes

 Work Environment:

• Office, laboratories, engineering prototype shop

 Physical Demands:

• The physical demands require the ability to lift 25 lbs.

 Travel Required:

• Occasional and up to 5% travel

 Required Education and Experience:

• Minimum Bachelor’s degree in engineering
• 10 years industry experience in life sciences, IVD, or medical device space
• Experience in scaling and transferring products from R&D to high volume manufacture
• Experience with managing multiple external vendors through development, scale up, commercialization and routine production
• Experience with CAPA
• Track record of developing a technology product through to successful product launch
• Highly motivated and independent, with the ability to work in a dynamic team environment.  
• Familiarity with lyophilized reagent components and cartridges
• Ability to develop plans and schedules for a complex project and lead them through completion
• Manufacturing engineering and process automation experience
• Experienced user of SolidWorks or similar CAD software
• Understands the use of agile and Scrum methods
• Excellent communication skills, verbal and written

 Work Authorization/Security-Clearance Requirements:

Must be eligible to work in the United States.

 Affirmative Action/EEO Statement:

Diversity, Equity, and Inclusion are not merely trendy buzz words to us; they are part of our core values.  We are committed to creating a community of well-rounded professionals from all ethnicities, nationalities, educational backgrounds, and genders.  This “melting pot” of differences is what fosters ideas and innovations. Our beliefs span beyond our walls and into the world, as reflected in outreach to various underserved domestic and global communities.

 Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job.  Duties, responsibilities, and activities may change at any time with or without notice.

 Other:

Sherlock requires employees to be fully vaccinated pursuant to Company policy (policy allows for potential exemptions for medical or religious reasons, consult with Human Resources for more information).