Job Description

Senior Sterilization & Materials Sciences Engineer (Medical Device experience) **Location of Work** Remote, US; San Diego, CA **Employment Type** Full Time Employee **Job Description** **Our mission** At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way. **Our brand promise** We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price. + **Remarkable service:** A seamless, personal process designed around you and your needs. + **Trusted performance:** Our product family is the result of years of experience championing surgeons and listening to their expertise. + **Outstanding value:** No matter the surgical specialty, we deliver quality products for all markets. **Our people promise** Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do. **Job Purpose Summary** This **Senior Sterilization and Material Sciences Engineer** spearheads the sterilization and materials science strategy for the Corza medical device business by ensuring sterilization and materials related activities are fit for the purpose of the products supported. Will ensure all cleanroom and controlled environment rooms are up to regulatory standards and ensure daily practices support a relevant monitoring cadence. The Senior Engineer works with other functional areas to support product transfers, new product introductions, material qualifications, and sustaining of existing products. Will manage product sterilization and microbiology deviations to correct and prevent reoccurrence. **What you will do** + Develop and drive the sterilization strategy for the medical devices organization. + Write, modify, and collaborate on sterilization validation protocols to ensure Corza Medical products continue to meet functionality, and design standards. + Leads sterilization and product release after sterilization activities. + Works with R&D, Quality Engineering, and other departments on new product introductions, sustaining product changes, product transfers, and other change control management to ensure sterile products are fit for their intended use and raw materials are selected in order to ensure compliance with applicable regulations and standards for restriction of hazardous substances and biocompatibility. + Evaluates product material for durability and performance. + Analyzes product test results to identify problems and devise actionable solutions. + Manages all sterilization deviations to understand root cause and implement appropriate corrective actions. + Ensures cleanroom and/ or controlled environment room validations and controls are up to the relevant standards and appropriate for the product being manufactured. + Leads any studies or analysis relevant to bioburden, cytotoxicity, pyrogenic, or other sterile-barrier related activities. **What you will need** + Bachelor's degree in Engineering, Chemistry, Microbiology or related field. + 5+ years of experience working in a sterilization engineering role in the medical devices sector. + Must have strong knowledge of quality management systems as they pertain to sterilization and microbiology requirements. + Experience in working with Gamma and EtO sterilization. + Experience with previous transfer of products from design to volume manufacturing. + Familiarity with regulations associated with hazardous substances, esp. in invasive and body contacting medical devices, incl. EU MDR, RoHS Directive, EU REACH. + Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities) required. + Knowledge of statistical analysis tools and their use in product design and manufacturing. + Six Sigma training is a plus. + Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. + Project management and leadership skills, including the demonstrated ability to lead project teams and resolve quality-related issues in a timely and effective manner. + Advanced computer skills, including statistical/data analysis and report writing skills. + Ability to work within a team and as an individual contributor in a fast-paced, changing environment. + Fluent in English required. Spanish fluency recommended. + Ability to travel up to 30%, especially if remote. **What we value** + **Customer First** - We deliver extraordinary experiences. + **Accountability** - We do what we say. + **Integrity** - We do what is right. + **Inspired** - We love what we do. + **One Global Team** -We before me, always. Join us today and **Excel@Corza** ! **A reasonable estimate of the current pay range for this role is ($95,000 - $135,000). Further, pay that is offered is based on geographic location, internal equity, market data, applicant's job-related skills, commensurate experience, required licensures, certifications and certain degrees.** **_Corza Medical offers a competitive benefits package including medical, 401K, vacation and sick time, paternal leave and other benefits._** **_Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics._** **Notice To Third Party Agencies** **:** **Corza does not accept unsolicited resumes from recruiters, employment agencies, or other staffing services. Any unsolicited resumes, including those submitted to hiring managers or other business leaders, will become the property of Corza Medical and Corza Medical will have the right to hire that candidate without reservation - no fee or other compensation will be owed or paid to the recruiter, employment agency, or other staffing service.** \#LI-Remote

Job Tags

Full time, Remote job,

Similar Jobs