Manufacturing Engineer

Manufacturing Engineer at inSync Staffing Manufacturing Engineer at inSync Staffing in Los Gatos, California Posted in 7 days ago.

Type:

full-time

Job Description:

Staff Manufacturing Engineer Direct hire position with salary range of $150,000 to $160,000

Location:

Campbell, CA SUMMARY:

An individual in this role uses advanced level experience to lead assigned projects/products to facilitate manufacturability through design technology transfer to manufacturing and ultimately scalability for commercialization. Areas of involvement include in-house and contracted manufacturing, manufacturing engineering, and equipment planning/engineering to meet the company's Quality System and customer requirements. This position may serve as a technical lead to for manufacturing engineering activities or teams.

ESSENTIAL DUTIES AND RESPONSIBILITIES

include the following:

• Lead manufacturing engineering initiatives for new product introductions, process changes, and product enhancements; support manufacturability strategy, cost targets, scalability, and production readiness in collaboration with R D, Quality, RA, Supply Chain, and Operations.
• Develop and maintain end-to-end manufacturing (raw materials to shipping) requirements, specifications, and documentation (e.g., MPIs, LHRs, inspection methods, assembly/packaging specs, labelling requirements) and ensure configuration control through DCO/change control processes.
• Design, procure, and oversee tooling, fixtures, equipment, and manufacturing line layouts to enable safe, timely, and cost-effective production, coordinate calibration and preventive maintenance activities in accordance with the Quality System.
• Establish and oversee in-house and contract manufacturing/packaging activities; select, qualify, and manage suppliers/CMs to ensure materials, components, and services are properly documented, meet specifications, and are controlled through incoming inspection/testing.
• Define and execute risk-based validation and verification strategies for manufacturing, packaging, and labelling (e.g., IQ/OQ/PQ, sealing/process validation, package integrity, distribution simulation, shelf-life/aging); author protocols, test plans, and reports and set acceptance criteria suitable for audit.
• Partner with cross-functional teams to define in-process inspections and testing; lead root cause investigations, CAPA support, and continuous improvement initiatives to improve yield, reliability, process capabilities, and lean manufacturing.
• Own project execution from early concept through clinical/production readiness: build and manage project plans, schedules, budgets, and deliverables; provide status updates and coordinate cross functional project team activities.
• Partner with Supply Chain to align inventory, raw material, and component requirements to build schedules; manage and be accountable for material issued to projects.
• Provide training, certification, and technical support as needed (e.g., MPI trainers and operators) and maintain compliance with GMP/GDP and applicable procedures.
• Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
• Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA, and Regulatory requirements.

Docusign Envelope ID:

5AAA321F-EF4A-4CF2-AA30-DF312AFBE3A1

• Actively promote and support the company's Management Review process.
• Inform responsible personnel of concerns involving product quality.
• Perform job functions in a safe and effective manner.

EDUCATION/EXPERIENCE

• Bachelor's degree in engineering, or related discipline and a minimum of 8 years of related experience or equivalent combination of education and work experience.
• MS in Engineering and experience in medical device industry preferred.
• Experience working under quality systems designed to meet governmental regulations such as

FDA QSR, ISO

13485, the MDD, and knowledge of relevant standards.

• Ability to detail project plans effectively.
• Strong knowledge of

GMP, GDP

procedures and requirements.

• Expertise in Design Control procedures and requirements.
• Experience with problem solving methodologies like Six Sigma and/or Root Cause Analysis.
• Excellent communications skills (both written and verbal) required.
• Ability to work independently or in team setting required.
• Certified Six Sigma Yellow Belt or Green Belt preferred.
• Project management experience preferred.

SUPERVISORY RESPONSIBILITIES

• May supervise more junior engineering or technician staff.

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.