Staff Manufacturing Engineer

Location: Campbell, CA

Department: Operations

• 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.

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

The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.

Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.