Report this Job
Nextern is hiring for the role Process Development Engineer, II(link removed) This role comes with competitive pay and a full benefits package (details below)
SUMMARY: As part of a multidisciplinary process development engineering team the Process Development Engineer II will be responsible for engineering support in the definition, design, process development, and production transfer of a wide variety of medical devices. This role includes collaborating with internal engineers, operations, and key client stakeholders.
DUTIES AND RESPONSIBILITIES:
Execute and provide oversight of qualification / validation activities to maintain compliance with Nexterns QMS.
Responsible for authoring and executing qualification / validation protocols and reports.
Responsible for authoring and executing of design / commissioning / qualification / validation documentation and support records to certify compliance with specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues.
Creates and follows procedures as required.
Create written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g. qualifications, risk assessments, and work instructions)
Develop solutions to complex problems, and/or makes moderate to significant improvements of processes, systems or product independently to enhance performance of the area
Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, and capability studies; to measure, monitor, improve and control the mfg line and select processes
Identify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes
Requirements
QUALIFICATIONS:
Bachelor's Degree (BA) from four-year college or university, or two to Three years of related experience and/or training, or equivalent combination of education and experience.
Design and manufacturing knowledge of plastics (extrusions, injection molding and/or precision parts), stamping, casting and/or sheet metal fabrication and/or: Experience in the design and development of interventional catheters.
Strong work ethic and professional commitment
Benefits
Nextern offers excellent benefits to fuel you in building a fulfilling life & career:
- Employer subsidized health insurance for employees
- Employer paid dental insurance
- Employer HSA contribution
- 401k plan with a company match
- 9 paid holidays (including your birthday!) + vacation and personal days
- Gym membership subsidy
- Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance
Nextern
