Manufacturing Engineer

Manufacturing Engineer

📍
Bay Area, CA (On-site: Richmond, CA)

🕒
Full-Time

🏢
Confidential | Drug Testing Industry (Stealth Mode)

Peoplework LLC is looking for a highly motivated Manufacturing Engineer to join our client’s team! The primary role will be to lead the daily operations and logistics to manufacture and distribute products for customers. This includes manufacturing production, movement of materials, and oversight of inbound and outbound inventory. The Manufacturing Engineer will partner with Quality and Engineering teams to manage multisite internal manufacturing lines, including line bring up, as well as line transfer to external contract manufacturers as production demands increase.

This role is ideal for someone who has a technical background, can establish, and communicate a vision and enjoys being “hands on”. This position reports to the SVP of Operations
.

• Own setup and qualification of internal manufacturing launch line.
• Lead internal manufacturing including daily build schedules and operator oversight to achieve production output targets.
• Manage daily and long-term customer order fulfillment, multi-site production planning, and inventory oversight.
• Define production cycle times, output requirements, and to ensure timely and cost-effective delivery of all inbound raw materials utilized in the manufacturing process and all customer products.
• Leverages lean skillset to manage manufacturing efficiency and quality through increased resource productivity, decreased process cycle times, and scrap reduction.
• Responsible for product quality and exceeding customer quality and delivery expectations.
• Assist troubleshooting activities related to product assembly, testing and service issues, including root cause analysis, to achieve a timely resolution.
• Collaborate with key stakeholders to ensure on time and in budget delivery of production milestones and quality support activities and investigations.
• Writes and reviews relevant manufacturing documentation such as Product specifications (SPCs), Manufacturing instructions (MPIs), Device History Records (DHRs), and other GMP documents.
• Deliver status reports, metrics and updates that provide visibility on production goals and outputs.
• Leads the team in staff training, maintenance and upkeep of manufacturing procedures and policies.
• Assist in hiring process and creation of relevant job descriptions.
• Provides guidance in make/buy decisions based on quality, schedule, and cost.

• Bachelor’s degree in engineering field, or a related discipline.
• Alternative:
  Associate degree, trade school, military technical training, or equivalent experience
• 3+ years relevant experience in manufacturing operations, including direct experience a regulated environment:
  Medical Device, Pharmaceutical, etc.
• Experience with manufacturing line start up and process qualifications.
• 1+ years of supervisory experience leading diverse teams in manufacturing operations.
• Demonstrated excellence achieving process improvements and associated operating efficiencies.
• Knowledge of GMP manufacturing principles and documentation best practices.
• Experience working within a structured quality management system.

• Provides open environment and promotes collaborative teamwork.
• Works independently and as part of an interdisciplinary team to achieve project goals and timelines as required.
• Strong verbal, written communication skills.
• Communicates efficiently with multiple people both internally and externally and prepare and present information to groups.
• Skillset to lead and motivate others in both matrixed and direct-line management environments.

• Join a confidential, early-stage drug testing company with meaningful impact on assay development and lab operations
• Opportunity to work closely with scientists, engineers, and quality teams
• Competitive compensation and benefits:
  Salary range: $135,000-$145,000/year.

🔒 Due to the stealth nature of the organization, additional details will be shared during the interview process.

Apply directly or message me to learn more.