Manufacturing Engineer II

SI-BONE, Inc•San Jose, CA

21d•$114,000 - $130,000

About The Position

SI-BONE is a fast-growing, publicly traded medical device company and an industry pioneer in minimally invasive sacropelvic solutions. Its mission is to help patients rise up and reach for the stars, and its vision is to lead globally in making sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy. 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, quality systems, and the transition of products into manufacturing operations. It also involves supplier-facility travel to observe and evaluate manufacturing and assembly processes. If potential non-compliance with applicable standards or regulations is identified, the employee has authority to hold products or QA/RA documentation from shipment or further processing and must report instances to a direct supervisor or above. The employee is expected to conduct business ethically and legally, follow company policies and applicable regulations, and report suspected violations or unethical behavior. SI-BONE does not tolerate retaliation for good-faith reporting.

Requirements

Bachelor’s degree in Manufacturing Engineering or Mechanical Engineering.
At least 4 years of manufacturing engineering experience, specifically with medical devices or components.
Experience with mechanical engineering in a medical-device environment, including CAD tools such as SolidWorks or Pro/E in conjunction with change-control processes.
Experience drafting manufacturing change documents.
Computer skills with Microsoft Excel, Microsoft Access, Microsoft Project, CAD, SolidWorks, Minitab, and ERP systems such as QAD.
Experience in 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 DOE methods.
Knowledge of FDA and functional requirements for sterile, non-sterile, disposable, and reusable devices.
Strong verbal and written communication skills.
Excellent time-management skills, initiative to meet deadlines, ability to prioritize workload, and ability to 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.
Must act honestly, ethically, and legally and comply with the Code of Conduct, company policies, the AdvaMed Code, and applicable laws and regulations.

Nice To Haves

Strong knowledge of manufacturing technologies for Class I and II medical devices, particularly in the orthopedic and implantable-device space.
Experience in multiple roles and responsibilities conducive to a company in product development and maturation.
Exposure to new product introduction and product launches.

Responsibilities

Create, improve, implement, and document processes and procedures for manufacturing, packaging, and labeling company products.
Perform supplier sourcing, evaluation, and management in conjunction with quality management systems and design for manufacturability.
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 accordance with Product Development and Quality Assurance functions.
Collaborate with peers to design and develop supply-chain manufacturing processes for new products, enhancements, product changes, fixtures, and tooling consistent with zero-defect goals.
Support Engineering Change Notice and Material Review Board 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 work on product packaging technologies, testing, validations, and labeling, including Instructions for Use, bar coding, and Global Trade Identification Numbers.
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 is identified, and report instances to a direct supervisor or above.
Report suspected violations of laws, regulations, the Code of Conduct, company policies, or other suspected unethical behavior.
Perform other duties as assigned.