Sterility Assurance Engineer - Military Veterans
at KARL STORZ Endoscopy-America, Inc.
Are you a dynamic and experienced engineer passionate about advancing sterilization processes for Single Sterile Use (SSU) medical devices?
Join KARL STORZ as a Sterile Single Use Sterilization Engineer and play a critical role in ensuring our products meet the highest regulatory standards, directly contributing to our core business strategy.
What's in it for me?
- Impactful Work: Play a crucial role in the development of life-saving medical devices, ensuring their safety and efficacy in the healthcare market.
- Career Growth: Work in a dynamic environment with opportunities for professional development, including exposure to cutting-edge sterilization technologies and regulatory practices.
- Collaborative Culture: Join a team that values collaboration across departments, allowing you to learn from and share knowledge with experts in engineering, regulatory affairs, and manufacturing.
- Innovative Environment: Be part of a family-operated company that prioritizes innovation and long-term vision over short-term gains, providing a stable and forward-thinking workplace.
- Professional Development: Access to training and development opportunities to enhance your skills in Lean Manufacturing, Six Sigma, and Continuous Improvement principles.
- Work-Life Balance: Enjoy a supportive work culture that recognizes the importance of work-life balance, allowing you to thrive both professionally and personally.
- Global Influence: Contribute to a company with a global reach, impacting healthcare standards and practices on an international scale.
What you'll be doing:
- Lead the validation and compliance of clean rooms and sterilization processes (experience with ethylene oxide preferred).
- Oversee 510k/PMA design validation, verification testing, and documentation for SSU devices.
- Manage relationships with sterilization providers and ensure rigorous release testing protocols.
- Collaborate with cross-functional teams on product designs and process improvements.
- Stay updated on sterilization technologies and regulations related to SSU devices.
- Represent KSUS in communications with regulatory bodies such as the FDA, ensuring all products meet federal standards.
- Implement and maintain internal quality systems in alignment with FDA Quality System Regulation, ISO 13485, and ISO 9001.
- Bachelor's degree in Toxicology, Biology, Chemistry, Chemical Engineering, or Material Science; an advanced degree is preferred.
- A minimum of 5 years of experience in various sterilization techniques, with a strong background in bringing SSU devices to market in the US.
- In-depth knowledge of CFR regulations pertaining to medical device sterilization and ISO 13485 standards.
- Proficiency in MS Office, especially Excel; strong data analytic skills.
- Strong analytical and problem-solving skills, with experience in Lean Manufacturing, Six Sigma, and Continuous Improvement principles.
- Proven project management capabilities; ability to manage multiple priorities effectively.
Who we are:
KARL STORZ is an independent, family-owned company headquartered in Germany's renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike.
With a 9000+ employees worldwide, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes. It 's not just about the tools we create-it's about the lives we change, together.
#LI-BL1
Eligible Employee Benefits
- Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!
- 3 weeks vacation, 11 holidays plus paid sick time
- Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
- 401(k) retirement savings plan providing a match of 60% of the employee's first 6% contribution (up to IRS limits)
- Section 125 Flexible Spending Accounts
- Life, STD, LTD & LTC Insurance
- We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
- Fitness reimbursement of up to $200 annually
- And much more!
Credentialing requirements at KARL STORZ
KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
Pay Transparency
The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
Equal Employment Opportunity & Reasonable Accommodation Statement
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.
Get in Contact
Vaccine requirements at KARL STORZ due to COVID-19
KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs. During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below on the process for requesting accommodation. Please click here to learn more about our overall response to COVID-19.
Employee Benefits Program Overview for U.S. Locations
- Medical / Dental / Vision including a state of the art wellness program and pet insurance, too!*
- 3 weeks’ vacation, 10 holidays plus paid sick time*
- 401K retirement savings plan providing a match of 60% of the employee’s first 6% contribution
- Section 125 Flexible Spending Accounts
- Life, STD, LTD & LTC Insurance
- Tuition reimbursement of up to $5,250 per year
- Fitness reimbursement up to $200 annually
- Employee referral program of up to $2,000 per hire
*Field sales, internships and part-time employees are not eligible except for where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in KARL STORZ benefits program.
KARL STORZ reserves the right to change or modify the employee’s job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employee must comply will all applicable KARL STORZ policies and procedures.
Equal Employment Opportunity & Reasonable Accommodation Statement
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at TaleoAdministrator@karlstorz.com.
Notice to Employment Agencies
This recruitment assignment is being managed directly by KARL STORZ’s Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required. Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by KARL STORZ Human Resources department will be ineligible for referral fees.
Bellingham, MA
Global company stability. Small company feel.
At KARL STORZ, you’ll have the opportunity to develop a more rewarding career filled with opportunities that you never thought possible.
Where technology meets humanity
KARL STORZ has been a leading provider of advanced endoscopy systems and related medical technology for more than 75 years.
We’re all about long-term, sustainable development—and that goes for both our products and our people. Our family-oriented culture gives you the tools you need to thrive at work and the time you need to recharge at home.
You’ll get to bring your authentic self to work every day and advance your career with a company that shares your goals—another reason why so many people on our team have stayed with us for so long.
Join KARL STORZ and experience a more enriching career, one where the work you do supports our goal to put best-in-class medical technology into the hands of skilled surgeons to save patient lives every day.