New Product Introduction (NPI) Engineer II, Nordson Medical MN
Full Time
Brooklyn Park, MN
Posted
Job description
Collaboration drives Nordson’s success as a market leader in Industrial Precision Solutions and Advanced Technology. Our employees thrive in an environment where we help each other reach our personal best and enable our company to continuously improve and grow, and our customers to succeed. You will find Nordson employees sharing our success by giving back in the communities around the world where we live and work.
Job Summary
A high-performing individual that will drive the development of medical device manufacturing processes from prototype assembly to production manufacturing. The desired individual will possess a broad range of medical device design and development skills and experience, as well as depth of knowledge of process development, process validation, lean manufacturing methodology, and statistical process control. The ideal candidate is a self-motivated individual who is excited by the prospect of working in a dynamic, entrepreneurial environment.
Essential Job Duties and Responsibilities
- Develop and document manufacturing processes for medical devices (disposable and reusable), catheters, implants, and/or packaging, from concept through market introduction.
- Drive process design and product design for manufacturability (DFM) to ensure robust and capable manufacturing processes.
- Plan and execute assembly, documentation and qualification of manufacturing line.
- Plan and execute process characterization studies to determine optimal process windows.
- Develop in-process inspections to ensure conformance to product requirements.
- Design and procure process equipment, tooling, fixtures, and assembly aids.
- Implement process improvements and controls to reduce assembly time and drive yield improvements.
- Conduct process risk analysis (PFMEA) for products under development and implement process controls to drive risk mitigations.
- Plan and execute process validations including IQ, OQ, PQ and PPQ activities.
- Prepare documentation release packages, including detail drawings, bills of material, and/or procedures. Approve Document Change Orders (DCOs) and obtain approvals from others as required.
- Ensure that all work satisfies the requirements of the company's Quality Manual, with particular emphasis on Design Control.
- Any other duties as assigned.
Education and Experience
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering or Manufacturing Engineering is required. Master’s degree in engineering, management or business is desired.
- 2-4 years' minimum of medical device product and process development experience is required. Catheter, reinforced catheter, balloon catheter experience a plus.
Skills and Abilities
- Demonstrated ability to bring products from concept to market.
- SolidWorks 3D CAD proficiency.
- Familiarity with FDA QSR and ISO 13485 medical device regulations.
- Knowledge of probability and statistics.
- Depth of knowledge in one or more clinical areas; interventional cardiology is desired.
- Depth of knowledge in one or more product areas; catheters is desired.
- Depth of knowledge in one or more technical areas, for example finite element analysis.
- Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.
Working Conditions and Physical Demands
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Travel Required
Minimal
Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.
Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law. All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.Third party recruiters and agencies should not contact employees of Nordson or its subsidiaries directly. Any resumes sent to a hiring manager or submitted to Nordson employees are considered unsolicited and property of Nordson. Nordson will not pay a placement fee unless the agency or recruiter has a signed contract with Nordson’s Human Resources department in advance of submitting a candidate for consideration. Verbal and written approvals will not be considered a valid contract for service.
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