A hands-on, high-performing individual to participate as a team member in establishing processes and manufacturing medical devices from concept through low volume production for client companies. This individual will possess a broad range of medical device manufacturing engineering skills and experience, as well as depth of knowledge with assembly processes, equipment, and tooling. The ideal candidate is a self-motivated individual who is comfortable rolling up their sleeves and working hands-on in the process. The individual should be excited by the prospect of working in a dynamic, entrepreneurial environment and interfacing directly with clients.Essential Job Duties and Responsibilities
Education and Experience Requirements
- Develop R&D pilot lines for new products and ensure design for manufacturability (DFM) through concurrent engineering practices.
- Establish robust assembly processes for both new products developed at Nordson Medical and those transferred into Nordson Medical.
- Support transfer of new product designs into clean room production environments.
- Specify, procure and install tooling, fixtures, and equipment to establish balanced production lines that meet time requirements.
- Establish test methods and conduct testing on components, devices, and processes.
- Support equipment maintenance and support equipment service needs.
- Work within integrated, product-specific project teams.
- Estimate assembly times, labor & space requirements, and equipment required for projects.
- Document processes in procedures and complete related documentation.
- Participate in risk analysis (FMEA) for new and existing products.
- Execute process qualifications and validations, including Gage R&R's and Design of Experiments.
- Any other duties as assigned
Skills and Abilities
- Bachelor's degree in Mechanical Engineering is preferred. Equivalent work experience may be considered
- Minimum of 1-2 years of experience in medical devices is required
- Hands-on experience with plastic assembly and processing, i.e. heat sealing, ultrasonic welding, injection molding, extrusions
- Familiarity with FDA QSR and ISO 13485 medical device regulations
Working Conditions & Physical Demands
- Ability to interact with client companies (customer focused) and co-workers in a professional manner.
- Willingness to support other functions as needed, in areas such as quality and design.
- Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.
- Professional writing skills required.
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
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.Please note: Nordson will not sponsor applicants for work visas for this position.
Associated topics: bio, bioinformatic, biological engineer, biomechanics, bioprocess, bioprocessing, biosynthetic, neuro, nutrition, parenteral