We’re a well-funded start-up . You’ll get a chance to wear many hats, be a part of a growing team, and have the potential for exciting financial and career growth. Here’s what sets us apart. We’ve set our sights on some of the biggest challenges facing biology today. We’re amassing a world class team of engineers, scientists, team builders and problem solvers to tackle these challenges heads-on. We’re passionate about developing the next generation technologies that will unravel the complexities of biology.
This is a unique opportunity to build, be part of an exciting start-up and be surrounded by good humans who are super capable, humble and down-to- earth. We are looking for a Senior Staff Manufacturing Process Engineer to join the team. This role will play a critical part in scaling and maturing manufacturing for the key consumable components of our novel life science instrument platform. The Sr.
Staff Manufacturing Process Engineer will o versee the consumable life cycle management (LCM) - from New Product Introduction (NPI) to drive c ontinuous i mprovement across Manufacturing and lead sustaining engineering for released consumable products — while representing Operations on cross-functional teams throughout the product lifecycle.
Essential Duties include but are not limited to the following: Lead new process transfer and qualification of new consumable manufacturing processes, transitioning products from R&D & pilot scale into full-scale production. Represent Consumable LCM on cross-functional teams throughout the product development lifecycle, providing manufacturability, process, and operational input into design and business decisions.
Own sustaining engineering support for released consumable products, including troubleshooting, root cause analysis (5-Why, fishbone, 8D) and implementation of corrective and preventive actions (CAPA). Investigate and resolve non-conformances and deviations. Identify, prioritize, and lead continuous improvement projects to improve yield, cycle time, capacity, and COGs across consumable manufacturing lines.
Partner with Product Development Team to develop a variety of tech transfer deliverables, including product BOM, manufacturing process design, pFMEA, control plan, equipment sourcing & onboarding and process work instructions. Partner with the broader Operation Team to complete operational readiness for new consumable products, including batch records, space control, labeling & packaging, supply chain readiness, MFG capacity & capability and staff training. Develop and optimize process performance monitoring system and apply Lean Manufacturing, Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE) methodologies to optimize processes and reduce variations.
Ability to lift to 30 lbs occasionally and to comply with personal protective equipment (PPE) requirements. Comfortable working hands-on in a manufacturing cleanroom environment as needed to support troubleshooting, validation, and process development activities. Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
Ability to comply with personal protective equipment requirements. Minimum Qualifications: Bachelor's degree in Mechanical, Chemical, Biochemical, Materials Science, or related Engineering discipline; advanced degree preferred. Typically requires 12 years of progressive experience in manufacturing/process engineering, spanning NPI, continuous improvement and sustaining engineering within a consumables, medical device, or life sciences manufacturing environment.
Demonstrated experience leading new product introductions from development through full-scale production launch. Strong hands-on experience in cleanroom and/or ISO/cGMP manufacturing environment