Manufacturing Engineering Technician and Drafter

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.

Title:



Manufacturing Engineering Technician and Drafter

Regular, Part Time, Exempt or Non-Exempt (covered by overtime):

Regular, Full time, Exempt

Hiring Manager

Director of Manufacturing

Preferred Location:

Santa Clara, CA

Desired Start Date

Salary Range:

$75,000 - $100,000

Travel: None, Occasional, Extensive

Occasional

General Responsibilities:





Specific Responsibilities:

The Manufacturing Engineer Technician 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. The Manufacturing Engineer will also work closely with engineers to edit CAD models and create engineering drawings.

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.

• Strong SolidWorks and geometric dimensioning and tolerancing knowledge. SolidWorks PDM user and work flow programming experience a plus.
• Work with manufacturing and design engineers to translate CAD models and design intent into mechanical drawings.
• Edit engineering drawings based on manufacturer or product development feedback.
• Ability to perform analyses to determine the feasibility of designs. FEA (ANSYS) knowledge a plus.
• Provide strong verbal and written skills in support of creation and development of work instructions, inspections documentation, change controls and visual aids as applicable.
• Experience with Engineering Change Orders routing and approval process related to specification updates, design improvements, and documentation updates.
• Collaborate with engineering and quality teams to assess the impact of specification changes. Document and communicate changes to relevant stakeholders.
• 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 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 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.
  
  

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.

We are aware of active recruitment scams using the SI-BONE name, in which individuals pose as our recruiters and post fake remote job openings and make fake job offers on the Internet. Please note, we will never make an offer of employment without conducting multiple rounds of interviews face-to-face using secure video-conferencing technology. We will never ask candidates to cash checks or make a payment in order to be considered for a position. SI-BONE only uses company email addresses, which contain "@si-bone.com" to communicate with candidates.

If you believe you've been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency at https://www.cisa.gov/be-cyber-smart/report-incident learn how to report it.