Staff Manufacturing Engineer, Capital Equipment

About the role

This position is based in our Campbell, California offices. This position is on-site & full-time.

Responsibilities

• Oversee the builds for capital hardware and equipment.
• Manage 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 and be accountable for material issued to production or engineering projects.
• Conceptualize and implement manufacturing improvements, tooling, and systems to increase productivity and/or improve yields.
• Define manufacturing or process related technologies to reduce manual operations and/or improve repeatability.
• Participate in the selection of suppliers for manufacturing components.
• Work closely with Quality to create manufacturing and process related SOPs and WIs.
• Develop manufacturing processes and Manufacturing Process Instructions (MPI’s) and lot history records (LHR’s) or Device History record (DHR’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.

Requirements

• BS in Engineering or related discipline and 8+ years of related experience; or MS in Engineering with 8+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
• Knowledge of and experience in pilot/production line set up and validation in Controlled Environment.
• 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.
• Familiar with GMP, GDP procedures and requirements.
• Familiar with 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.
• Working knowledge of quality system requirements and compliance (e.g. traceability, QSRs, ISO, MDD/MDR requirements) and other applicable regulations.
• Experience working with ERP/MRP/Documentation control systems

Qualifications

• BS in Engineering or related discipline and 8+ years of related experience; or MS in Engineering with 8+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry

Skills

• Knowledge of and experience in pilot/production line set up and validation in Controlled Environment.
• 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.
• Familiar with GMP, GDP procedures and requirements.
• Familiar with 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.
• Working knowledge of quality system requirements and compliance (e.g. traceability, QSRs, ISO, MDD/MDR requirements) and other applicable regulations.
• Experience working with ERP/MRP/Documentation control systems

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.

Pay

Salary Range: $147,000 – 167,000 /annually

Schedule

Full-time