Manufacturing Engineer II

SI-BONE; San Jose (CA); On-site; USD 114,000 - 130,000; Full time

Benefits offered by this job

Bonus

Stock

Job summary

SI-BONE, a growing medical device company, seeks a Manufacturing Engineer to partner with Product Development and external manufacturers. You will help build, improve, and document processes for manufacturing, packaging and labeling of sacropelvic products.

The role demands collaboration across functions, strong CAD/PLM tooling experience, and adherence to FDA QSR and ISO13485 in a fast-paced environment. Travel to supplier facilities is expected.

Qualifications

• Bachelor's degree in Manufacturing or Mechanical Engineering.
• Minimum 4 years of manufacturing engineering experience in medical devices.
• Experience with Class I/II medical devices and orthopedic implants preferred.
• Experience drafting manufacturing change documents and working in design for manufacturability.

Responsibilities

• Develop, improve, implement and document manufacturing, packaging and labeling processes.
• Collaborate with suppliers and QA/RA to ensure compliance with FDA QSR/ISO13485 and related regulations.
• Support ECN/MRB activities including root cause investigations of non-conforming materials.
• Participate in product launches and transitions to manufacturing operations.
• Assist with tools, fixtures, processes and costs optimization for zero-defect production.

Skills

Cross-functional collaboration

Time management

Initiative

Leadership potential

Education

Bachelor's Degree in Manufacturing Engineering or Mechanical Engineering

Tools

CAD

SolidWorks

Pro/ENGINEER (Creo/Parametric)

Microsoft Excel

Microsoft Access

Microsoft Project

Minitab

ERP systems (QAD)

Job description

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy.

The Manufacturing Engineer will work closely 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. The employee has the responsibility to report any instances to their direct supervisor or above.

The Manufacturing Engineer must at all times act and conduct company business in an honest, ethical and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code and all applicable laws and regulations, whether national, regional, state or local. This individual is encouraged, expected, and required to report any suspected violations of laws, regulations, the Code or any other Company policy, and all other suspected unethical behavior. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

General Responsibilities

• Mechanical engineering experience in a medical device environment which includes working with CAD, Solid Works, Pro E, etc. in conjunction with change control processes.
• Perform supplier sourcing, evaluation and management in conjunction with quality management systems in the design for manufacturability.
• Provide strong verbal and written skills in support for creation and development of standard operation procedures, work instructions, inspections documentation, change controls and visual aids as applicable.
• Create and maintain accurate documentation of tool drawings, design concepts and orders, in accordance with the Product Development and Quality Assurance functions.
• Collaborate with peers to design and develop supply chain manufacturing processes for new products, enhancements, product changes, and related fixtures and tooling that are consistent with zero defect level.
• Support Engineering Change Notice (ECN) and related Material Review Board (MRB) activities including disposition and root cause investigation of non-conforming materials.
• Participate through the project validation phases with transition to manufacturing operations which includes efficiency gains/improvements post pre-product status (includes tooling, fixtures, processes and costs).
• Participate in cross-functional teams with a focus on product packaging technologies, testing, validations and labeling (including IFUs – Instructions for Use) with Bar Coding and use of GTINs (Global Trade Identification Numbers).
• Assist in the evaluation of returned materials/products.
• Support and adhere to company policies, procedures, goals and objectives, QSR/FDA regulations and evaluate suppliers for good manufacturing practices.
• This position requires travel to supplier facilities to observe and evaluate supplier manufacturing and assembly processes.
• Perform other duties that may be assigned as necessary.
• Support the SI-BONE Quality System.

Qualifications and Attributes

• Bachelor's Degree in Manufacturing Engineering or Mechanical Engineering.
• Minimum of 4 years' manufacturing engineering experience, with specific experience in medical devices/components
• Strong knowledge of manufacturing technologies for Class I and II medical devices, specifically in the orthopedic and implantable space is highly preferred.
• Experience in multiple roles and responsibilities conducive of a company in a current state of product development and maturation.
• NPI and product launch exposure
• Experience drafting manufacturing change documents
• Computer skills: Microsoft Excel, Microsoft Access, Microsoft Project, CAD, SolidWorks, Minitab, and ERP systems (QAD).
• Experience working in a dynamic medical device manufacturer and/or contract medical device manufacturer
• Experienced in designing, analyzing, acquiring and qualifying manufacturing 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

There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits, please visit www.si-bone.com/risks.