Medical Device Project Lead — Lean & Regulatory
Dormont Manufacturing Co
Freudenberg Medical LLC in Minnesota seeks an engineering professional to lead cost modeling, make-vs-buy decisions, and guide Lean/Six Sigma initiatives in medical device manufacturing. You will ensure design history files, device master records, and validation activities meet regulatory requirements, mentor team members, and deliver on scope, schedule, and budget. Bachelor’s degree required; 3+ years in medical devices; ISO/GMP knowledge. #J-18808-Ljbffr Dormont Manufacturing Co
- ...global technology group is looking for a Project Manager to lead the development of cost models, track... ...over 3 years of experience in the Medical Device industry and 2 years in a leadership... ...knowledgeable about ISO standards and Lean/Six Sigma methodologies. This...RegulatoryMedical deviceFull time
$85k - $115k
A leading medical device manufacturer is looking for a skilled Project Manager in Minnetonka. You will lead projects focused on manufacturing cost models, track performance metrics, and ensure compliance with ISO standards. The ideal candidate has a degree in a relevant...RegulatoryMedical device$78k - $156k
...the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...countries. JOB DESCRIPTION: NPI Project Sourcing Lead Working at Abbott... ...Administration (FDA) regulations, other regulatory requirements, Company policies,...RegulatoryMedical deviceLong term contractFull timeFor contractorsLocal areaWorldwideShift work- ...Medical Device Assembler Medical Device Assembler Shift Timings: Mon-... ...cardioverter defibrillators (ICDs), leads, and related assemblies. The... ...Management Systems (QMS) and regulatory requirements. Maintain... ...in continuous improvement and Lean Manufacturing initiatives to...RegulatoryMedical devicePermanent employmentShift work
$39 - $42 per hour
...Work in collaboration with Team Leads to achieve production plans.... ...environment, i.e. medical devices or other industries governed... ...Federal, State and Corporate regulatory policies. Experienced with root cause problem solving and lean manufacturing tools/practices...RegulatoryMedical deviceHourly payWork at office- ...Responsibilities: Lead development of accuratemanufacturing... ...for development, project progression, and... ...‑improvement and Lean/Six Sigma... ..., innovation, and regulatory excellence across... ...history files, device master records,... ...years’ experience in Medical Device or related...RegulatoryMedical deviceWork at office
- ...Entry-level assembly aptitude (medical device experience a plus). Good hand... ...defibrillators (ICDs), leads, and related medical device assemblies... ...a basic understanding of Lean Manufacturing. Participate... ...Management Systems (EMS), and other regulatory requirements. Ability to read...RegulatoryMedical deviceContract work
$18.75 per hour
...Responsibilities Assemble, repair, and test medical devices according to standardized procedures... ...Quality Management Systems (QMS) and regulatory requirements. Maintain accurate... ...Participate in continuous improvement and Lean Manufacturing initiatives to improve...RegulatoryMedical deviceHourly payShift work$17 - $18.75 per hour
...the production of high-quality medical devices within a manufacturing cell.... ...defibrillators (ICDs), leads, and related medical device assemblies... ...a basic understanding of Lean Manufacturing. Participate... ...Management Systems (EMS), and other regulatory requirements Ability to read,...RegulatoryMedical deviceHourly payContract workRemote workShift work- ...position will support projects aimed towards designing... ...product introductions Lean manufacturing... ...and testing of product devices Recommend and implement... ...Systems (EMS), and other regulatory requirements. Complies... ...predictable attendance Medical device experience...RegulatoryMedical deviceFor contractorsShift work
- Hims & Hers is looking for a VP, Regulated Device Engineering to lead the medical device business. This role involves overseeing R&D, ensuring compliance... ..., and a proven track record in product development and regulatory processes. Hims & Hers offers a competitive salary,...RegulatoryMedical device
$14.35 - $28.75 per hour
...the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...Demonstrates a basic understanding of Lean Manufacturing.... ...Management Systems (EMS), and other regulatory requirements Shift...RegulatoryMedical deviceHourly payShift work$88.25k - $117.5k
...engineering duties and project assignments based on... ...guidance from supervisor or lead engineers. Use... ...design solutions for medical devices. Use 2D and 3D cad... ...Service, Supply Chain, Regulatory Affairs, Vendors, Suppliers... ...Experience with Lean Six Sigma / (DFMA) Design...RegulatoryMedical deviceTemporary workFor contractorsLocal area$14.35 - $28.75 per hour
...the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...Demonstrates a basic understanding of Lean Manufacturing.... ...Management Systems (EMS), and other regulatory requirements Required Qualifications...RegulatoryMedical deviceHourly payShift workAfternoon shift$61.3k - $122.7k
...the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded... ...methodologies (e.g., Six Sigma and Lean Manufacturing) Lead the investigation... ...Systems (EMS), and other regulatory requirements. Complies with...RegulatoryMedical deviceWork experience placementShift work- ...the production of high-quality medical devices within a manufacturing cell.... ...defibrillators (ICDs), leads, and related medical device assemblies... ...a basic understanding of Lean Manufacturing. Participate... ...Management Systems (EMS), and other regulatory requirements. Ability to read...RegulatoryMedical device
- ...join a small team supporting a growing medical device startup. We are currently seeking a... ...and procedures to ensure compliance with regulatory requirements. Contribute to process... ...device manufacturing. Familiarity with Lean Manufacturing principles and continuous...RegulatoryMedical device
$70.2k - $105.32k
Medica is seeking a Risk Adjustment Compliance Project Manager to lead compliance-focused initiatives ensuring accuracy and regulatory adherence for Risk Adjustment programs. You will collaborate across teams, manage audits, and develop policies aligned with CMS regulations...Regulatory3 days per week$100.9k - $151.3k
...Control Manager Cretex Medical is a leading contract manufacturer... ...for the medical device industry. Our customers... ...control strategies, regulatory compliance, and... ...Requirements: Lean/Six Sigma experience... ...help you figure out a project and get it done right...RegulatoryMedical deviceHourly payContract workTemporary workLocal areaShift work- Freudenberg Medical LLC is seeking an experienced professional in medical device design and development in Minnesota. The role focuses on anticipating regulatory challenges, proposing product and process improvements, and leading complex technical initiatives. The candidate...RegulatoryMedical device
$11.41 per hour
...three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in... ...a technical lead for projects, including validation... ...with medical device regulatory requirements. Provide... .... Experience with Lean or Six Sigma methodologies...RegulatoryMedical deviceHourly payFull timeShift work- Laborie Medical Technologies Corp in Minnetonka, MN is seeking a Medical Writer II to develop clinical and regulatory documents and presentations. This role involves collaboration with internal... ...experience and knowledge of medical device regulations. Laborie offers various...RegulatoryMedical device
$39 - $42 per hour
...A leading medical device firm in Minnetonka is seeking a Production Supervisor to lead and develop team members while ensuring safety and quality standards in production. The ideal candidate has 3-5 years of leadership experience in a regulated manufacturing environment...Medical deviceHourly pay- ...Minnesota, is seeking a Risk Adjustment Compliance Project Manager. This role is responsible for ensuring the accuracy and regulatory compliance of Medica’s Risk Adjustment... ...risk adjustment. Responsibilities include leading compliance initiatives, managing audit activities...Regulatory
$100.9k - $151.3k
...Overview About Cretex Medical: Cretex Medical is a leading contract... ...assemblies for the medical device industry. Our... ...compliance with applicable regulatory requirements (e.g.,... ...initiatives using Lean and risk-based... ...s requirements ~ Project management skills...RegulatoryMedical deviceHourly payContract workTemporary workWork experience placementWork at officeLocal area$113.03k - $165.77k
...job is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory... ...field. Minimum Experience: 7+ years of US and International medical device regulatory submission/approval experience, to include FDA,...RegulatoryMedical deviceImmediate start$75k - $112.6k
...Overview About Cretex Medical Cretex Medical is a leading contract... ...assemblies for the medical device industry. Our customers... ..., and adherence to regulatory and customer... ...~ Advanced GD&T ~ Lean manufacturing ~ Lead... ...help you figure out a project and get it done right...RegulatoryMedical deviceHourly payContract workTemporary workWork at officeLocal area- ...environment. Organizational Effectiveness & Talent Strategy Lead organizational design, workforce planning, and succession... ..., and EHS to ensure HR practices align with healthcare and medical device regulatory requirements. Influence HR policy governance and enterprise...RegulatoryMedical device
- ...(Non-Manager) Category Devices/Disposables Date Needed By... ...Stereotaxis' systems have received regulatory clearance in the United... ...visit Position Summary: Medical manufacturing assembly in a... .... • Participate in various Lean/Continuous Improvement...RegulatoryMedical deviceWork at officeImmediate startShift work
- ...Medical Assembly Location: Minnetonka 1st shift: 4:45/5am-3:... ...production of high quality medical devices within a manufacturing cell.... ...defibrillators (ICDs), leads, and related medical device assemblies... ...Systems (EMS), and other regulatory requirements Background...RegulatoryMedical deviceTemporary workDay shiftAfternoon shift
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