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$48.36 per hour
...JOB DUTIES: Fabrication of new butt welded and socket welded piping spools from ½ “to 24” piping. Read prints, P&ID’s and ISO’s Makes welding repairs to Refinery equipment as needed. Installation of new piping spools Removal of old piping spools Hydro...SuggestedHourly payFull timeLocal areaMarathon Petroleum
Maple Grove, MN2 days ago$95k - $105k
...in oil & gas, aerospace, semiconductor, or high-purity equipment. ~ Certified Welding Inspector (CWI) through AWS ~ Knowledge of ISO 9001, ASME codes (B31.1, B31.3), AWS D1.1, ASTM standards. ~ Ability to interpret drawings, review welding documents (WPS, PQR, WQTR...SuggestedFull timeFor contractorsLocal areaFlexible hoursDay shift- ...to both technical and non-technical audiences. Align all updates with international medical device standards and regulations (FDA, ISO 14155, and other applicable GCP frameworks). Requirements Proven expertise in GCP-related project or content development within...SuggestedFull timeContract work3 days per week
$110k - $150k
...working with sensitive or regulated technologies (Controlled Goods) ~ Familiarity with regulatory and quality compliance standards (e.g., ISO 9001, NIST 800-171). What to Expect at Work Physical Demands The physical demands described here must be met by an...SuggestedTemporary workWork at office$95k - $155k
...preferably in the medical device industry, focusing on systems engineering. · Familiarity with system designs that adhere to IEC 60601, ISO 13485, ISO/EN 14971, and IEC 62304 standards is essential. · Experience with requirements management tools will be considered a...SuggestedTemporary work- ...operating CNC machines to machine precision parts making tooling and fixtures to support operation control and product quality courses, certificate or degree in CNC machining operation and programming ~ Familiarity with ISO 13485 and 9001, as well as FDA standards....SuggestedHourly payFull timeImmediate startMonday to FridayShift work
$28 - $30 per hour
...changes, servicing industries such as medical, military, aerospace, and large OEMs globally. The facility is a clean 90,000 square foot ISO:9001 certified shop. Employees benefit from medical and dental insurance, company-paid life and short-term disability insurance, 401(...SuggestedWeekly payPermanent employmentTemporary workWork at officeDay shift- ...functional, and compliant product designs. The ideal candidate combines strong engineering fundamentals with an understanding of FDA, ISO 13485, and ISO 14971 requirements, collaborating with cross-functional teams to deliver high-quality, manufacturable, and regulatory-...SuggestedRemote work
- ...metrics, and tools. 5+ years' experience in the medical device industry. - Working knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971). - Working knowledge of new product design and development in medical devices. - Working knowledge of the...SuggestedPermanent employment
- ...outputs, verification, and validation meet regulatory and organizational requirements. Participate in risk management activities (ISO 14971), including FMEA and hazard analysis. Review and maintain Design History Files (DHF), technical documentation, and change...SuggestedRemote work
$100k - $110k
...metrics, and tools. 5+ years' experience in the medical device industry. - Working knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971). - Working knowledge of new product design and development in medical devices. - Working knowledge of the...SuggestedPermanent employment$150k - $180k
...analysis, and debugging ~ Experience with embedded systems (C/C++ a plus) ~ Familiarity with regulatory requirements (IEC 60601, ISO 13485, or similar) ~ Excellent communicator with proven ability to lead and mentor others Benefits: ~ Medical & Dental Insurance...SuggestedFull timeDay shift$120k - $200k
...test platforms for high-mix or high-reliability electronics Understanding of calibration, traceability, and compliance standards (ISO, IPC, MIL-STD, etc.) Demonstrated ability to mentor teams on test strategy, fixture design, or measurement best practices Strong...SuggestedTemporary workFor contractorsH1bLocal areaWork visaFlexible hours- ...process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines). Keeps up to date on all ISO/EN/FDA/MDR and other Product Development related regulatory requirements and relay this information to the Product Development group...Suggested
$99.1k - $188.3k
...include: Interpret and apply relevant cybersecurity standards and regulations (e.g., FDA/CMDE/MDCG Cybersecurity Guidance, IEC 62443, ISO 14971, HIPAA, GDPR) to ensure product compliance. Stay current with emerging regulations and standards related to medical device...SuggestedHourly payWork at officeWorldwideShift work3 days per week$110k - $150k
...manufacturing operations. This role is critical to driving process innovation, equipment validation, and product quality in compliance with ISO standards. Responsibilities + Lead process development activities for catheter manufacturing, including prototyping, scale-up, and...Permanent employmentContract workTemporary work$15.77 - $25.24 per hour
...is preferred ~ Familiar with and able to navigate MES or New Critical Manufacturing System preferred ~ Basic knowledge of FDA and ISO regulations preferred ~ Willingness to learn and take on additional responsibilities ~ Must have excellent hand and eye...Hourly payWork experience placementWork at officeLocal areaWorldwide$140k - $160k
..., and approval of Design History Files (DHF), Device Master Records (DMR), and risk management documentation in compliance with FDA, ISO, and IEC standards. Partner with R&D and Systems Engineering to ensure design inputs and outputs are clearly defined, traceable, and...Full timeTemporary workDay shift$105k - $135k
...technical documentation to support audits and submissions. Interpret and apply applicable quality and regulatory standards (FDA, ISO, IEC) during all phases of development. Provide technical input during design reviews and offer data-driven recommendations to strengthen...Full timeTemporary workDay shift- ...Maintain strict adherence to design control and quality system requirements , ensuring full traceability and compliance with FDA, ISO 13485, and IEC standards . Must-Have Qualifications Bachelor’s degree in Electrical Engineering or related discipline...Contract workRemote work
$70k - $95k
...and workmanship standards. + Lead process/product/system/supplier audit and improvement actions follow up. + Industry standards (e.g. ISO) + Compliance audit + Safety audit etc. + Follow up the EC (Engineering Change), SPCN (Supplier Process Change Notification) to...Temporary workWork at office- ...Experience with pharmaceutical or combination medical device development Working knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820, 210, 211 (US QS Regulation), ISO 13485 (Quality Management Systems), EU MDR, and IEC 62366-1 (...Hourly payWorldwideRelocation packageShift work3 days per week
- ...teams in support quality initiatives to improve and develop processes with the understanding of regulatory compliance requirements of ISO and the FDA. What you will be doing: Based in our Maple Grove, MN office, the Quality Engineer will ensure the company meets...Contract workWork at officeLocal areaRemote work
- ...Skills, Knowledge, Experience & Qualifications ~ High School diploma or equivalent. ~5+ years' overall experience in Medical Device (ISO 13485, FDA QSR) manufacturing environment. ~5+ years' equivalent work experience directly applicable to Primary Duties and...Temporary workWork experience placementLocal areaMonday to FridayFlexible hoursShift workDay shift
- ...expertise with Class III combination devices in both U.S. and EU markets. ● Deep knowledge of FDA regulations, EU MDR, MDCG guidance, ISO 13485, ISO 14971, and related global standards. ● Ability to work independently and mentor junior regulatory staff. ● Experience...Hourly payWork at officeLocal areaWorldwideRelocationRelocation packageShift work3 days per week
- ...communication skills with both technical and non-technical audiences Experience with design/production of medical devices under ISO 13485 Understanding of manufacturing methods related to catheter fabrication and experience working with extrusion, braiding, lamination...Local areaRemote work
- ...returned product analysis and corrective and preventive action (CAPA) ~ Experience with medical device standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization. ~ Experience in design...Hourly payWork at officeLocal areaWorldwideRelocation packageShift work3 days per week
- ...Experience with class III medical devices BS in Electrical Engineering Previous R&D experience Strong knowledge of QSR and ISO standards Medical device experience ASQ certification Requisition ID: 617275 Minimum Salary: $ 82600 Maximum Salary:...Hourly payWork at officeLocal areaWorldwideRelocation packageShift work3 days per week
- ...collaboration and candidate care. ~ Ability to thrive in a fast-paced, hands-on environment. Preferred Experience Knowledge of FDA, ISO, or GMP requirements related to hiring in regulated industries. Previous experience supporting multiple manufacturing sites or...Hourly payContract workWork experience placementShift work
- ...Modeling Software or equivalent ~ Strong communication skills (verbal & written) ~ Demonstrated use of Quality tools/methodologies ~ ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis ~ Travel as...Hourly payWork at officeLocal areaWorldwideRelocation packageShift work
