Systems Test Engineer II

Location: California

Systems Test Engineer II page is loaded## Systems Test Engineer II locations:
Valencia CAtime type:
Full time posted on:
Posted Todayjob requisition :
R-At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

The Test Engineer works closely with R&D, and Design Quality to ensure that products are developed with the highest level of quality in mind and in compliance with FDA and ISO
13485 regulations. Looking for a person that works at the system level and can go deep into details.

What you'll be doing
* Work closely with R&D to design and test medical devices.
* Ensures design controls and regulatory requirements are followed to develop products with the highest level of quality for our patients.
* Write and execute test protocols.
* Support Risk Management process (Hazard and Risk Analysis).
* Works with multiple project schedules and manages competing priorities.
* Facilitates Design Review activities of new products and works closely with product design teams to ensure quality considerations during all stages of product development.
* Support field complaints and troubleshoot field returns.
* Holds oneself and others accountable to conduct business in a manner compliant with Bioventus’ Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
* Other duties as assigned.

What you'll bring to the table
* Bachelor’s degree in an Engineering discipline - Electrical, Computer Science or Biomedical Engineering preferred.
* Minimum 3 years’ experience, or 1 year with a Master’s degree (preferably within the medical device industry).
* Software, Firmware, Electronics related experience highly desired.
* Understanding of, and ability to interpret, regulations and guidelines governing medical devices including knowledge of ISO 13485 and 21 CFR 820.
* Experience using, understanding, and interpreting regulations/guidelines governing supplier quality and development of electro-medical equipment and/or software including knowledge of the IEC 60601-1 family of standards, ISO 62304, 62133, 14971 and EMC requirements.
* Data analysis & critical thinking skills. Ability to adapt & learn quickly.
* Good written & verbal communication; responsiveness.
* Ability to work well within a team and relate to all levels within the company.
* Hybrid work environment Apply now! Hit the “Apply” button to send us your resume and cover letter.
* Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation.
** All
* * individuals, regardless of personal characteristics, are encouraged to apply.*# Innovations for Active Healing that Enhance the Body’s Ability to Heal Bioventus is a global leader of innovations for active healing. Through a combination of internal product development, product/business acquisition, and distribution agreements, we will bring to market products which address a growing need for clinically effective, cost efficient, minimally invasive medical treatments, that engage and enhance the body’s natural healing processes.

At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

** Who is
** We are the market leader in developing clinically proven and cost-effective solutions for pain treatment & joint preservation, restorative therapies and bone graft substitutes with products recognized for their safety, innovation and effectiveness. **$500****+ million
** in annual revenue
** 1100+
** employees worldwide Helping
** 7
* *** 00,000+ people
** every year

The Bioventus team always puts patients at the forefront, and their needs are the priority in the choices we make and actions we take.
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