Sr Manufacturing Engineer

Overview

Senior Manufacturing Engineer —

Location:

Campbell, CA. This position is full time and on-site.

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 with the company’s Quality System and customer requirements.

• 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.

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

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

$125,000 – 136,000 annually. Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate’s work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer.

Join Us! Imperative Care

The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. External recruiters/staffing agencies are requested not to contact Imperative Care employees directly to present candidates. Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.