{"schemaVersion":"jobsearcher.job.v1","id":"ff73dbeee3087ecaefb5a3db","url":"https://jobsearcher.com/jobs/ff73dbeee3087ecaefb5a3db","canonicalUrl":"https://jobsearcher.com/jobs/ff73dbeee3087ecaefb5a3db","title":"Principal Process Development Engineer","description":"As part of a multidisciplinary process development engineering team the Process Development Engineer 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.\nDUTIES AND RESPONSIBILITIES:\nIdentify technologies that meet the manufacturing needs of new product development programs\nDefine design criteria and author associated documentation including User Requirements Specifications and Equipment Specifications for highly automated equipment\nOversee vendor design and fabrication of automated manufacturing equipment\nLead the definition and execution of the Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ) and process characterization.\nRepresent the organization as a primary technical contact for specific projects and initiatives with vendors; communicates with internal and external customers and suppliers at various levels\nLead efforts for production release of finished goods and components. This includes BOM’s/routings and other ERP required information.\nDevelop solutions to complex problems, and/or makes moderate to significant improvements of processes, systems or product independently to enhance performance of the area\nManage major/complex projects, involving delegation of work and review of work products, at times acting as a team leader\nMake 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\nIdentify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes\nUtilize project mgmt skills to drive process development, vendor adherence to program schedules, and validation projects to completion; on time and on budget\nCreate written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g. qualifications, risk assessments, and work instructions)\nWork with product development engineering to drive back lessons learned as new products are being developed\nProvide training and certification for trainers as required\nLead efforts to investigate and develop new technology related to combination products\nRequirements\nQUALIFICATIONS:\nBachelor’s Degree from a four-year college or university in Industrial Engineering, Mechanical Engineering or related field.\nMaster’s Degree in Engineering is a plus\n10+ years of experience, preferable in the medical device field.\nDesign 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.\nDemonstrated ability to collaborate with, support and direct mechanical design, review CAD models, part drawings and BOMs for accuracy and manufacturability.\nExperience directing small to medium size projects.\nAbility to work with electronic document and project management systems to track work product, deliverables and progress.\nDemonstrated ability to provide complete and accurate work product; material selection, designs, drawings and other documents that accurately reflect product requirements and transition smoothly into production.\nStrong work ethic and professional commitment\nThe desire to both innovate and serve internal and external customers by meeting and exceeding project deliverables and timelines\nLanguage Skills:\nAbility to write reports, business correspondence, or procedure manuals.\nAbility to effectively present information and respond to questions from groups of managers, clients, customers, and the general public\nComputer Skills:\nShould have knowledge of: SolidWorks, Office Suite\nPreferred Qualifications:\nWorking knowledge of data collection, data analysis, evaluation, and scientific method\nBenefits\nNextern offers excellent benefits to fuel you in building a fulfilling life & career:\nEmployer subsidized health insurance for employees\nEmployer paid dental insurance\nEmployer HSA contribution\n401k plan with a company match\n9 paid holidays (including your birthday!) + PTO and Personal days\nGym membership subsidy\nEmployee Short Term Disability, Long Term Disability, and AD&D Life Insurance\nSalary Range for This Position: $140,000 - $160,000.\nNextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.","company":"Nextern","rawCompany":"nextern","city":"Maple Grove","state":"MN","isRemote":false,"isActive":false,"createdAt":"2026-04-12T17:46:32.061Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2141.00","title":"Mechanical Engineers","slug":"mechanical-engineers"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"}],"industries":[{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Principal Process Development Engineer","description":"As part of a multidisciplinary process development engineering team the Process Development Engineer 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.\nDUTIES AND RESPONSIBILITIES:\nIdentify technologies that meet the manufacturing needs of new product development programs\nDefine design criteria and author associated documentation including User Requirements Specifications and Equipment Specifications for highly automated equipment\nOversee vendor design and fabrication of automated manufacturing equipment\nLead the definition and execution of the Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ) and process characterization.\nRepresent the organization as a primary technical contact for specific projects and initiatives with vendors; communicates with internal and external customers and suppliers at various levels\nLead efforts for production release of finished goods and components. This includes BOM’s/routings and other ERP required information.\nDevelop solutions to complex problems, and/or makes moderate to significant improvements of processes, systems or product independently to enhance performance of the area\nManage major/complex projects, involving delegation of work and review of work products, at times acting as a team leader\nMake 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\nIdentify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes\nUtilize project mgmt skills to drive process development, vendor adherence to program schedules, and validation projects to completion; on time and on budget\nCreate written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g. qualifications, risk assessments, and work instructions)\nWork with product development engineering to drive back lessons learned as new products are being developed\nProvide training and certification for trainers as required\nLead efforts to investigate and develop new technology related to combination products\nRequirements\nQUALIFICATIONS:\nBachelor’s Degree from a four-year college or university in Industrial Engineering, Mechanical Engineering or related field.\nMaster’s Degree in Engineering is a plus\n10+ years of experience, preferable in the medical device field.\nDesign 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.\nDemonstrated ability to collaborate with, support and direct mechanical design, review CAD models, part drawings and BOMs for accuracy and manufacturability.\nExperience directing small to medium size projects.\nAbility to work with electronic document and project management systems to track work product, deliverables and progress.\nDemonstrated ability to provide complete and accurate work product; material selection, designs, drawings and other documents that accurately reflect product requirements and transition smoothly into production.\nStrong work ethic and professional commitment\nThe desire to both innovate and serve internal and external customers by meeting and exceeding project deliverables and timelines\nLanguage Skills:\nAbility to write reports, business correspondence, or procedure manuals.\nAbility to effectively present information and respond to questions from groups of managers, clients, customers, and the general public\nComputer Skills:\nShould have knowledge of: SolidWorks, Office Suite\nPreferred Qualifications:\nWorking knowledge of data collection, data analysis, evaluation, and scientific method\nBenefits\nNextern offers excellent benefits to fuel you in building a fulfilling life & career:\nEmployer subsidized health insurance for employees\nEmployer paid dental insurance\nEmployer HSA contribution\n401k plan with a company match\n9 paid holidays (including your birthday!) + PTO and Personal days\nGym membership subsidy\nEmployee Short Term Disability, Long Term Disability, and AD&D Life Insurance\nSalary Range for This Position: $140,000 - $160,000.\nNextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.","datePosted":"2026-04-12T17:46:32.061Z","dateModified":"2026-04-12T17:46:32.061Z","hiringOrganization":{"@type":"Organization","name":"Nextern","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Maple Grove","addressRegion":"MN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ff73dbeee3087ecaefb5a3db"},"url":"https://jobsearcher.com/jobs/ff73dbeee3087ecaefb5a3db"}}