Staff Manufacturing Engineer

Imperative Care • Campbell, CA

6d • $150,000 - $160,000 • Onsite

About The Position

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 an individual technical innovation contributor or, as lead to a technical team of manufacturing engineers.

Requirements

• 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.
• 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.
• Excellent communications skills (both written and verbal) required.
• Ability to work independently or in team setting required.
• Must be able to travel.

Nice To Haves

• MS in Engineering and experience in medical device industry is preferred.
• Project management experience preferred.

Responsibilities

• Oversee the construction of fixtures for new products or processes or current product enhancements.
• Establish and oversee in-house and contract manufacturing activities and relationships to ensure products are manufactured in accordance with product plans and quality/regulatory requirements.
• Ensure Supply Chain is aware of inventory, raw materials, and component requirements per the planned build schedule; manage/be accountable for material issued to projects.
• Implement manufacturing improvements, tooling, and systems to increase productivity and yields.
• Participate in the selection of suppliers for manufacturing components.
• Develop manufacturing processes and Manufacturing Process Instructions (MPI’s) and lot history records (LHR’s) in collaboration with R&D and Quality.
• Perform time studies for each manufacturing process and identify process development initiatives.
• Ensure that all products are manufactured in compliance with the company Quality System, customer needs, budgetary requirements, schedule requirements, and the regulatory requirements.
• Work with Quality personnel to define in-process inspections and testing and resolve quality and yield issues through continuous improvement projects.
• Provide oversight and coordinate cross-functional operations project team activities from early project conceptualization through clinical testing.
• Create, maintain, and manage manufacturing tasks of project schedule, and ensure that critical timelines and/or budgets are established and met.
• Participate in manufacturing team meetings to ensure adequate communication between members and develop positive, proactive working relationships with other staff.
• Develop manufacturing specifications for products and validation activities with Quality/IQ/OQ/PQ.

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