Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Job Description:
Global Design Control Process Owner (Solventum)
3M Health Care is now Solventum
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You’ll Make in this Role
As the Global Design Control Leader within the Quality organization of Solventum, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:
- Own and implement the Global Design Control Process
- Manage process updates in alignment with global regulations and standards including ISO 13485:2016, 21CFR820, and EU MDR
- Advance the Design Control Process as needed to support Solventum’s businesses while maintaining compliance
- Drive consistency in execution towards robust product launches and efficient change management
- Elevate competence in the principles of design control across the enterprise through effective global process deployment, coaching best practices cross-functionally, and guiding training plans.
- Support audits and other interactions with regulatory agencies and notified bodies
- Transform culture and passion around process and compliance as mechanisms to enable better, safer, smarter healthcare.
Your Skills and Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
- Bachelor’s Degree or higher in an engineering, science, or quality discipline from an accredited institution AND Twelve (12) years of combined experience in Medical Device, Pharmaceutical, or Combination Product experience with a Product Quality or Engineering focus in a private, public, government or military environment.
- Five (5) years proven experience in quality management systems defining and deploying the design control process
Additional qualifications that could help you succeed even further in this role include:
- Master’s degree in Quality Assurance / Management, Chemistry, Biology / Microbiology, Material Science, or related discipline from an accredited institution
- 15+ years experience of combined experience in Medical Device, Pharmaceutical, or Combination Product experience with a Product Quality or Engineering focus in a private, public, government or military environment.
- Demonstrated leadership in the application of design controls for new product development or major product redesign that may include Six Sigma experience and/or certification related to the design and manufacture of new Medical Device, Pharmaceutical, or Combination Products
- Scientific knowledge and experience in development of medical devices and relevant regulations and standards applicable to medical device compliance, such as ISO 13485 and ISO 14971
- Proven experience in quality management systems defining and deploying the design control process across multiple geographies
- Proven experience interacting with regulatory agencies and notified bodies
- Excellent leadership, communication, influencing, change management, and interpersonal skills, with the ability to effectively collaborate with stakeholders at multiple levels
Work location:
Travel: May include up to 10% domestic and/or international
Relocation Assistance: May be authorized
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
Applicable to US Applicants Only:The expected compensation range for this position is $207,348 - $253,425, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards
Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.
Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.
Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
Solventum Global Terms of Use and Privacy Statement
Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.
Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the
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