Manufacturing Engineer II
$114,000–$130,000 year
On-site · El Camino, California, United States
Job Summary
Manufacturing Engineer II to work with SI-BONE’s Product Development Team and outsourced manufacturing suppliers to create, improve, implement and document processes and procedures to manufacture, package and label the company’s products. In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, or ISO14971), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing and must report any instances to their direct supervisor. The role requires collaboration across cross-functional teams on packaging technologies, labeling (including IFUs and GTINs), and transition to manufacturing during project validation phases, with travel to supplier facilities. The position demands adherence to QSR/FDA regulations, quality systems, and continuous process improvement, including ECN and MRB activities. The candidate should have strong communication skills, documentation discipline, and a focus on zero-defect manufacturing, with responsibilities spanning design for manufacturability, change control, SOP creation, and manufacturing tooling and equipment qualification.
Required Qualifications
- Bachelor’s Degree in Manufacturing Engineering or Mechanical Engineering
- Minimum of 4 years’ manufacturing engineering experience, with specific experience in medical devices/components, packaging and labeling desirable
- Computer skills: Microsoft Excel, Microsoft Access, Microsoft Project, CAD, SolidWorks, Minitab, Label software and ERP systems (QAD)
- Experience working in a dynamic medical device manufacturer and/or contract medical device manufacturer
- Experience in multiple roles and responsibilities conducive of a company in a current state of development and maturation
- Strong knowledge of manufacturing technologies for Class I and II medical devices, specifically in the orthopedic and implantable space is highly preferred
- Strong knowledge of sterile packaging technologies, testing, validation, labeling and concepts
- Experienced in designing, analyzing, acquiring and qualifying manufacturing fixtures, tools and equipment
- Familiar with statistical tools and concepts such as ANOVA and DOE methods
- Knowledge of FDA and functional requirements for sterile, non-sterile, disposable and reusable devices
- Excellent time management skills, take initiative to meet deadlines and the ability to prioritize workload and minimal supervision
- The ability to network and interact effectively with a broad range of associates spanning varied disciplines and responsibilities
- Must have a strong passion for product and process excellence and customer satisfaction
- Salary range: $114,000 - $130,000. The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors.
- Supplemental pay: bonus and stock
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