Description
:
Under the direction of the Manager of R&D, this individual will be primarily supporting maintenance of business projects (MOB) with some potential support on New Product Development (NPD) projects. This position will have emphasis on executing against all requirements of a Design History File (DHF) including creating all product development documentation, protocols, and testing design requirements. The individual will work as a core team member supporting all aspects of the Change Development Process (CDP) as well as work with remote teams to execute on projects. This position will interact with other Research and Development groups, and Sales and Marketing, Manufacturing, Quality, Regulatory Affairs, Planning/Logistics, Packaging/Labeling and Outside Partners.
This role is onsite in our Mansfield, MA facility. The position is hybrid (3+ days onsite).
Responsibilities:
1. Design History File (DHF) Documentation and adherence to guidelines and requirements associated with FDA/QSR design controls.
2. Participate in multi-departmental teams to manage product sustaining activities.
3. Create BOM’s, component/finished good specifications
4. Initiate and execute Engineering Change Orders to the Quality Management System (QMS) electronic change management system
5. Writing technical documents within an engineering environment, verification, validation, stability protocols, test reports and others.
6. Tests developments, test set ups and execution.
7. Manage assigned projects to established timelines and generate/maintain project status updates.
8. Travel up to 10%
Qualifications:
9. Bachelor’s degree in mechanical engineering or a related field, preferred or relevant work experience.
10. 0-3 years of experience in medical product development or related field preferred.
11. Previous experience working as an engineer is a plus.
12. Technical understanding of Mechanical Engineering concepts, preferred
13. Basic knowledge of Medical Devices and the design controls, preferred
14. Good communication (oral and written) and interpersonal skills.
15. Proficient computer skills with Excel, Word and PowerPoint, preferred
16. Experience in creating engineering documents, preferred
17. Develop solutions to well defined technical problems, preferred
18. Works effectively in a diverse group.
19. Capable of developing a schedule for smaller development tasks.
20. Basic knowledge of 3-D CAD systems, preferred
21. Basic knowledge of Plastics Injection Molding/Extrusion Designs, preferred
22. Basic knowledge of Design for Six Sigma (DFSS) and Design for Manufacturing and Assembly (DFMA), preferred
23. Manufacturing Experience is a plus.
What is expected of you and others at this level
24. Applies basic concepts, principles and technical capabilities to perform routine tasks
25. Works on projects of limited scope and complexity
26. Follows established procedures to resolve readily identifiable technical problems
27. Works under direct supervision and receives detailed instructions
28. Develops competence by performing structured work assignments
Anticipated salary range: $71,600 - $102,200
Bonus eligible: No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
29. Medical, dental and vision coverage
30. Paid time off plan
31. Health savings account (HSA)
32. 401k savings plan
33. Access to wages before pay day with myFlexPay
34. Flexible spending accounts (FSAs)
35. Short- and long-term disability coverage
36. Work-Life resources
37. Paid parental leave
38. Healthy lifestyle programs
Application window anticipated to close: 8/15/2025 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
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Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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