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Arden Hills, Minnesota, United States Boston Scientific Full timeAbout Boston ScientificBoston Scientific is a global leader in medical science, committed to solving the challenges that matter most. Our mission is to advance science for life, transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we...
Scientist III
3 months ago
Additional Location(s): N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.
About the role:
An exciting opportunity to join the multi-functional Arden Hills Analytical Laboratory. Scientist III will partner with laboratory staff and management, supplier quality, and operations to develop, validate, and perform quality control and investigation trace metals testing to support production of medical devices. This role will be primarily laboratory will some opportunities to work special projects.
Your Responsibilities Will Include:
- Perform trace metals analysis using established instrumentation settings, processing, and reporting methods.
- Develop new trace metal test methods for quality control and investigational testing using ICP/OES or ICP/MS.
- Perform routine laboratory testing in accordance with FDA and other regulatory requirements, and internally established procedures.
- Assure the quality of medical device and combination products by supporting material and finished goods release testing.
- Proactive communication and coordination of material and finished goods release testing to ensure work is completed on required customer timelines.
- Escalate laboratory resourcing and testing capabilities constraints with laboratory management and customers.
- Partner with external laboratories to ensure material and finished good testing is completed per Boston Scientific's quality and business requirements.
- Lead equipment qualifications, software validation, method validations, and method transfer activities.
- Support documentation and investigation for out of specifications, atypical results, and laboratory deviations.
- Support technical writing and ownership of laboratory procedures, work instructions, and test methods.
- Support internal and external regulatory audits.
- Drive continuous improvement, optimization, and other special projects for the laboratory.
Required Qualifications:
- Minimum of a BS degree in Chemistry, Biology, or related degree
- Minimum of 2-4 years of technical experience in laboratory setting with basic skills such as pipetting, good weighing practices, utilization of class A glassware, solution and standard preparations, and handling of chemicals.
- Minimum of 4 years of industry experience operating trace metals equipment such as ICP/OES or ICP/MS.
- Working knowledge of cGMP, 21 CFR Part 11, and/or ISO Ability to understand other medical device and combination product regulations and standards.
- Previous validation experience (analytical test equipment, test method, and/or software).
- Previous experience as laboratory coordinator/project manager.
Preferred Qualifications:
- Minimum of 5 years of technical experience in laboratory setting with basic skills such as pipetting, good weighing practices, utilization of class A glassware, solution and standard preparations, and handling of chemicals.
- Strong communication, presentation, facilitation, and project management skills.
- Ability to work with a diverse team and contributes to an inclusive work environment
Requisition ID: 587178
Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § , Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.