Principal Sterilization Engineer / Microbiologist - Remote Job

Boston Scientific Maple Grove , MN 55369

Posted 8 months ago

Additional Locations: (n/a)

Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your life's work.

This position has the option to be based remotely

About the role:

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support. Serve as technical expert in the EtO sterilization, Radiation, Steam, Chemical and other Sterilization modalities

Your responsibilities include:

  • Provides leadership role on championing departmental or cross-functional engineering initiatives.Provide sterilization assurance and engineering support to manufacturing operations

  • Provides project direction, coaching, and mentoring for engineering and technical team personnel.

  • Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.

  • Mentor for technical guidance for identifying and resolving quality issues.

  • Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.

  • Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

  • Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

What we're looking for in you:

Minimum Qualifications

  • BS in Engineering or Microbiology

  • 8-13 years of quality and/or operations experience

  • Ability to travel 25-30% approx 50% domestic/50% international

  • Demonstrated expertise in ethylene oxide sterilization processes; knowledgeable in e-beam, Gamma, terminal liquid chemical sterilization, steam sterilization, reprocessed devices, etc.

  • Subject Matter Expert for FDA, ISO, MDD and and/or quality requirements associated with developing medical device

  • Working understanding of US and International regulations associated with all modes of sterilization

  • Experience with IQ, OQ and PQ processes

  • Experience with lean manufacturing and Sterilization Best Practices

  • Strong trouble shooting and problem solving skills

  • Excellent communication and presentation skills

  • Pro-active, energetic, self-assured professional with high personal integrity and ability to collaborate, influence and develop positive interpersonal relationships

Preferred Qualifications

  • Regulated industry/Medical Device experience a plus

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.

Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

Requisition ID: 439187


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Principal Sterilization Engineer / Microbiologist - Remote Job

Boston Scientific