Manufacturing Engineer II

SI-BONE•San Jose, CA

About The Position

The Manufacturing Engineer works closely with SI-BONE’s Product Development Team and outsourced manufacturing suppliers to create, improve, implement, and document processes and procedures for manufacturing, packaging, and labeling company products. The role supports product development and maturation, supplier manufacturing, process validation, and the transition of products into manufacturing operations. The employee may hold products or QA/RA documentation from shipment or further processing if potential non-compliance with applicable standards or regulations is identified, and must report suspected issues to a supervisor or above. The position requires adherence to company policies, the Code of Conduct, the AdvaMed Code, and applicable laws and regulations, including reporting suspected violations or unethical behavior. This role also requires travel to supplier facilities to observe and evaluate manufacturing and assembly processes.

Requirements

Bachelor’s degree in Manufacturing Engineering or Mechanical Engineering.
At least 4 years of manufacturing engineering experience, including specific experience in medical devices or components.
Experience with mechanical engineering in a medical device environment, including CAD software such as SolidWorks or Pro/ENGINEER and change-control processes.
Strong verbal and written communication skills.
Experience drafting manufacturing change documents.
Computer skills with Microsoft Excel, Microsoft Access, Microsoft Project, CAD, SolidWorks, Minitab, and ERP systems such as QAD.
Experience working for a dynamic medical device manufacturer and/or contract medical device manufacturer.
Experience designing, analyzing, acquiring, and qualifying manufacturing tools and equipment.
Familiarity with statistical tools and concepts such as ANOVA and Design of Experiments (DOE) methods.
Knowledge of FDA and functional requirements for sterile, non-sterile, disposable, and reusable devices.
Excellent time-management skills; initiative to meet deadlines; ability to prioritize workload and work with minimal supervision.
Ability to network and interact effectively with associates across varied disciplines and responsibilities.
Strong commitment to product and process excellence and customer satisfaction.
Ability to comply with applicable laws and regulations, company policies, the Code of Conduct, and the AdvaMed Code.

Nice To Haves

Strong knowledge of manufacturing technologies for Class I and II medical devices, particularly in orthopedics and implantable devices.
Experience in multiple roles and responsibilities suited to a company in product development and maturation.
New product introduction (NPI) and product launch exposure.

Responsibilities

Create, improve, implement, and document processes and procedures for manufacturing, packaging, and labeling products.
Perform supplier sourcing, evaluation, and management in conjunction with quality management systems and design for manufacturability.
Create and develop standard operating procedures, work instructions, inspection documentation, change controls, and visual aids.
Create and maintain accurate documentation of tool drawings, design concepts, and orders in coordination with Product Development and Quality Assurance.
Collaborate with peers to design and develop supply chain manufacturing processes, fixtures, and tooling for new products, enhancements, and product changes, with a focus on zero defects.
Support Engineering Change Notice (ECN) and Material Review Board (MRB) activities, including disposition and root-cause investigation of non-conforming materials.
Participate in project validation phases and transition to manufacturing operations, including post-pre-product efficiency improvements involving tooling, fixtures, processes, and costs.
Participate in cross-functional teams focused on packaging technologies, testing, validations, and labeling, including Instructions for Use (IFUs), bar coding, and Global Trade Identification Numbers (GTINs).
Assist in evaluating returned materials and products.
Support and adhere to company policies, procedures, goals, objectives, the SI-BONE Quality System, and QSR/FDA regulations; evaluate suppliers for good manufacturing practices.
Travel to supplier facilities to observe and evaluate supplier manufacturing and assembly processes.
Hold products or QA/RA documentation from shipment or further processing when potential non-compliance with applicable standards or regulations is identified, and report instances to a direct supervisor or above.
Report suspected violations of laws, regulations, the Code of Conduct, or company policy, as well as suspected unethical behavior.
Perform other duties as assigned.