Cleanliness and sterility assurance Engineer

Envista Holdings Corporation • Yorba Linda, CA

1d

About The Position

The Cleanliness and sterility assurance Engineer is responsible for supporting the cleanliness and sterility assurance of medical devices for our dental implant manufacturing in Karlskoga (Sweden) and Yorba Linda (USA). Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place. Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.

Requirements

• Strong technical background (MSc or equivalent) in relevant field (Biotechnology or Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry or related science)
• 5 years of experience in MedTech industry or equivalent
• Solid knowledge of regulatory requirements and standards related to contamination control and cleanliness control or ability to rapidly develop expertise to function independently with minimal supervision (ISO 13485, ISO 11137-1&2)
• Solid understanding of manufacturing environment and process validation
• Solid expertise in statistical data analysis
• Fluent in English (spoken and written), Swedish is an asset.
• Excellent verbal & written communication skills
• Strong analytical skills

Responsibilities

• Define validation studies with respect to microbiological/physical/chemical Cleanliness for new equipment and equipment changes
• Perform cleanliness process validation of updated/new equipment
• Define cleanliness monitoring activities for updated/new equipment together with contamination control manager
• Maintain contact material mapping
• Build and maintain a framework of procedures and templates to ensure standard work for the cleanliness validation and monitoring activities.
• Support the biological and microbiological safety strategy
• Plan and coordinate external tests execution with approved vendors (at need).
• #LI-PG1

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level