Sr Manufacturing Engineer

Imperative Care • Campbell, CA

4d • $125,000 - $136,000 • Onsite

About The Position

An individual in this role uses strong hands-on experience to execute and deliver assigned projects/products to ensure manufacturability, supporting technology transfer from design to manufacturing and ultimately scalability for commercialization. This position will complete projects related to in-house and contracted manufacturing, manufacturing engineering, and equipment planning/engineering in accordance the company’s Quality System and customer requirements.

Requirements

• Bachelor’s degree in engineering, or related discipline and a minimum of 5 years of related experience; or equivalent combination of education and work experience.
• Demonstrated knowledge and experience in pilot/production line setup and validation in controlled environment, including work under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD.
• Ability to detail project plans effectively.
• Familiar with GMP, GDP procedures and requirements.
• Excellent communication skills (both written and verbal) required.
• Ability to work independently or in team setting required.
• Must be able to travel.
• Experience with problem solving methodologies like Six Sigma and/or Root Cause Analysis.

Nice To Haves

• Experience supporting medical device packaging and labeling activities in a regulated environment, including packaging/labeling documentation, issue troubleshooting, and packaging/labelling verification/validation deliverables preferred.
• Certified Six Sigma Yellow Belt or Green Belt preferred.
• Project management experience preferred.
• Catheter manufacturing or medical device experience preferred

Responsibilities

• Execute manufacturing activities for in-house and contract manufacturing, including supplier/CM relationships, to ensure builds meet product plans and quality/regulatory requirements.
• Partner with Supply Chain to align raw material/component availability to build schedules; track and be accountable for material issued to production/projects.
• Develop and maintain manufacturing and packaging/labelling processes, specifications, and documentation (e.g., MPIs, LHRs, packaging work instructions/specs, BOM/configuration, labelling requirements) in collaboration with R&D, Quality, Regulatory, and Marketing; support establishment of manufacturing line readiness and contribute to DCOs for manufacturing engineering.
• Support and execute product/process development and transfer activities including prototype builds, time studies, manufacturability improvements, and cost/yield optimization to support smooth transition into manufacturing and achievement of cost targets.
• Engage and support verification/validation activities with Quality/RA/R&D, including manufacturing IQ/OQ/PQ and packaging validations (e.g., sealing/process validation, package integrity, distribution simulation, shelf-life/aging), including protocol execution support, data review, and report inputs.
• Define in-process inspections and testing with Quality; troubleshoot manufacturing, packaging, printing, and labelling issues (e.g., barcodes/variable data, print quality, adhesion/legibility, handling/shipping damage) and implement corrective actions through structured problem solving and continuous improvement.
• Determine, procure, and verify tooling, fixtures, and equipment; plan equipment/workflow layouts; manage equipment design/development and coordinate calibration and preventive maintenance in conformance with the Quality System.
• Contribute to cross-functional project execution from early concept through clinical testing by developing and maintaining project schedules, executing assigned tasks, and ensuring timelines/budgets are met; participate in team meetings and maintain positive working relationships.
• Conduct methodical root cause investigations and provide guidance to prevent recurrence.

Benefits

• Employee Benefits include a stake in our collective success with stock options, bonus, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees