Associate Director, Sterility Assurance
1 month ago
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.
About the role:
The Associate Director, Sterility Assurance, will serve as the global technical leader in design for sterilization in support of new product development across all divisions of BSC.
You will have managerial responsibility for a high performing team of subject matter experts in sterility assurance, sterilization modalities, microbiological methods, device reprocessing and microbiological quality.
You will build and maintain your and your teams state of the art knowledge and capabilities by actively networking with the internal and external scientific, technical and regulatory communities.
Your responsibilities will include:
- Influencing the company's strategic and tactical directions and financial results globally through the application of technical leadership, knowledge, and expertise.
- Supporting new product development, collaborating with product teams and suppliers to provide design inputs as well as to validate sterile and microbiologically controlled products.
- Cross functional collaboration and influence across multiple divisions and functions including quality, regulatory, global supply chain, and R&D.
- Developing strategies with respect to design for sterilization, sterilization modality selection, sterilization cycle design and product validation approaches.
- Providing input in the design of manufacturing processes, controlled environments and packaging from a microbiological standpoint.
- Conducting research into novel sterilization modalities, or novel applications of existing sterilization modalities and their impact on materials and product functionality and lethality.
- Interacting with external regulators and various levels of company management, working across many functional areas.
Required qualifications:
- Bachelor's degree with Engineering, Microbiology, Biology, Chemistry or related discipline.
-5+ years of direct people leadership experience is required.
- Experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility.
- Demonstrated capability to lead and train a diverse, multinational community of practice with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity.
- Experience in interacting with Regulatory Authorities.
- Demonstrated competency in multiple industrial terminal sterilization methods (e.
- Proven track record on trouble shooting microbiological and/or sterilization process non conformances and out of specification test results and providing resolution to issues via robust CAPA.
- High level knowledge of standards including AAMI and ISO.
- Must be able to travel 20% of the time (domestic and global)
Preferred qualifications:
- Master's or PhD degree in Microbiology, Biology, Engineering or related discipline.
- Competency in additional technical areas such as reprocessing and microbiology laboratory operations experience
- Experience with conducting technical assessments of in house and contract sterilization processes or contract microbiological laboratories
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 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 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.
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.
-
Associate Director, Sterility Assurance
2 months ago
Maple Grove, Minnesota, United States Boston Scientific Full timeAdditional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt 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,...
-
Sterile Processing Specialist
7 days ago
Maple Grove, Minnesota, United States AdeIphi MedicaI Staffing Full timeAbout the JobWe are seeking a highly skilled Sterile Processing Specialist to join our team at AdeIphi MedicaI Staffing. As a key member of our team, you will be responsible for ensuring the highest standards of sterilization and decontamination in our facilities.Key ResponsibilitiesDecontamination and sterilization of medical equipmentPreparation and...
-
Medical Equipment Technician
7 days ago
Maple Grove, Minnesota, United States AdeIphi MedicaI Staffing Full timeAbout the JobWe are seeking a highly skilled Sterile Processing Specialist to join our team at AdeIphi MedicaI Staffing. As a key member of our team, you will be responsible for ensuring the highest level of sterility and safety in our medical equipment.ResponsibilitiesDecontamination and sterilization of medical equipmentPreparation and packaging of sterile...
-
Design Assurance Engineer
2 months ago
Maple Grove, Minnesota, United States Advantage Technical Full timeWe are seeking a highly motivated Design Assurance engineer for our Global Medical Device client. About the role: The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. Employee will work with high-performance cross-functional sustaining team to ensure safety,...
-
Quality Assurance Technician
3 months ago
Maple Grove, Minnesota, United States Steris Corporation Full timeSynergy Health, a wholly owned subsidiary of STERIS Corporation, delivers a range of specialized outsourced services to healthcare providers and other clients concerned with health management. These services are aimed at supporting our customers to improve the quality and efficiency of their activities, while reducing risks to their patients and clients....
-
Project Director
7 days ago
Maple Grove, Minnesota, United States Data Recognition Corporation Full timeAbout the RoleWe are seeking an experienced and dedicated Project Manager to join our team at Data Recognition Corporation. As a Project Manager, you will be responsible for leading projects from initiation to delivery, ensuring timely completion, and meeting customer expectations.Key ResponsibilitiesProject Planning and Execution: Develop and manage project...
-
Warehouse Associate II
1 month ago
Maple Grove, Minnesota, United States R.S. Hughes Co, Inc Full timeImagine a company that recognizes excellence in not only the products it sells, but also in its employees. R.S. Hughes Company, Inc. is that company. We hold ourselves to the highest standards of quality and professionalism - and we treat our employees like the valuable assets they are.Founded in 1954, R.S. Hughes Co., Inc. is a dynamic, North American...
-
Warehouse Associate
4 weeks ago
Maple Grove, Minnesota, United States Border States Full timeBe part of a growing, successful company in an exciting and challenging field. Border States is 100% employee-owned, which means you're empowered to make decisions, find solutions and receive rewards for your hard work.This position will be located in: Maple Grove , MN Job SummarySupports the operation functions of wire cutting in the warehouse. Runs the...
-
Software Quality Engineer II
2 months ago
Maple Grove, Minnesota, United States Boston Scientific Full timeAdditional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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...
-
Quality Assurance Specialist II
1 week ago
Inver Grove Heights, Minnesota, United States C4 Technical Services Full timeQuality Assurance Engineer IILocation: RemoteKey Responsibilities: Maintain and enhance IT Quality Assurance and Testing standards and methodologies. Develop and implement automated test scripts as an integral member of a product development team. Perform code evaluations and ensure proper application of automation frameworks or Quality Assurance &...
-
LPN Mental Health
3 months ago
Maple Grove, Minnesota, United States Allina Health Full timeNumber of Job Openings Available:1Date Posted:April 24, 2024Department: AHG PsychiatryShift:Day (United States of America)Shift Length:8 hour shiftHours Per Week:40Union Contract:Non-UnionWeekend Rotation: NoneJob Summary:Allina Health is a not-for-profit health system that cares for individuals, families and communities throughout Minnesota and western...
-
Precision CNC Operator
2 weeks ago
Maple Grove, Minnesota, United States PDS Tech Commercial Full timeJob OverviewPDS Tech Commercial, Inc. is proud to collaborate with a distinguished client, a frontrunner in electromechanical manufacturing and supply chain solutions, to identify a skilled CNC Operator for our operations.Shift: 1st shift 6am to 2:30pmCompensation: $33.00 to $36.00 per hourIn this role, you will play a crucial part in the setup, operation,...
-
Therapist or Assoc Therapist- Weekends
2 months ago
Maple Grove, Minnesota, United States PrairieCare Full timeTherapist or Assoc Therapist- WeekendsCategoryClinician - Counselor. Therapists. Social Worker. Psychologist.Job LocationsUS-MN-Maple GroveTypeRegular Part-TimeAbout UsWe are a psychiatric healthcare system, dedicated to providing mental healthcare for all, with seven locations in the Minneapolis/St. Paul metro area, and two additional sites located in...
-
Statistical Analyst
2 months ago
Maple Grove, Minnesota, United States Data Recognition Corporation Full timeStatistical Analyst Maple Grove, MN, USA Req #480Tuesday, July 9, 2024PurposeThe Statistical Analyst will work under the direction of a Psychometrician using specifications to write and execute programs to perform psychometric analyses and technical reporting using large data sets from large-scale educational assessments programs and/or products. The...
-
Plant Operations HVAC Technician
2 weeks ago
Maple Grove, Minnesota, United States Sprung Services, Inc. Full timeJob OverviewPosition: Plant Operations HVAC TechnicianThe Plant Operations HVAC Technician plays a crucial role in ensuring the effective functioning and upkeep of all facility systems within a cGMP (current Good Manufacturing Practice) environment. This includes overseeing HVAC systems, boilers, chillers, deionized water systems, compressed air systems,...
-
Senior Operational Technology Analyst
1 month ago
Maple Grove, Minnesota, United States Boston Scientific Full timeAdditional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt 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,...
-
Principal Procurement Specialist
4 weeks ago
Maple Grove, Minnesota, United States Upsher-Smith Laboratories, LLC Full timeProcure respective commodity and requisitioned materials to support the sales plan, production schedule and general business operations. Manage complex, high impact projects related to the procurement of business critical materials and commodities Leads purchasing and procurement activities to support corporate projects. Works with suppliers to provide...
-
Sr. Product Quality Specialist
2 months ago
Maple Grove, Minnesota, United States Upsher-Smith Laboratories, LLC Full timeUpsher-Smith Laboratories, LLC is seeking a Sr. Product Quality Specialist to share time between Plymouth, MN, and Maple Grove, MN, to be responsible for providing Quality support to the Upsher pharmaceutical product portfolio, inclusive of products in development through the lifecycle of discontinuation. In addition, this position will also represent QA on...
-
Senior Design Quality Engineer
1 month ago
Maple Grove, Minnesota, United States Boston Scientific Full timeAdditional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt 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,...
-
Garden Center Sales Associate
1 week ago
Cottage Grove, Minnesota, United States Niemann Foods Full timeGarden Center Sales AssociateWe are seeking a skilled and detail-oriented Garden Center Sales Associate to join our team at Niemann Foods. As a key member of our garden center team, you will be responsible for providing exceptional customer service, maintaining product knowledge, and ensuring the cleanliness and organization of the department.Key...