Insight Global | Engineering Lead- Medical Products NPI | saint petersburg, fl

4 days ago


saint petersburg, United States Insight Global Full time

Position Summary:

We are seeking a highly skilled and experienced Engineering Lead to join our dynamic New Product Introduction (NPI) team for medical devices. This role will be responsible for collaborating with cross-functional teams in the introduction of innovative medical products to manufacturing, ensuring adherence to regulatory standards, quality requirements, and project timelines.

The ideal candidate will have a strong background in engineering (mechanical, electrical, catheter, or biomedical), with significant experience in NPI for medical devices. You will lead the engineering efforts, collaborate with R&D, regulatory, manufacturing, planning and procurement, and quality teams, and drive product launch to manufacturing.


Key Responsibilities:

  • Lead NPI Projects: Own and drive the technical aspects of the product launch process, ensuring that engineering milestones are met within scope, schedule, and budget. Provide leadership across all stages of product introduction.
  • Team Leadership & Mentorship: Collaborate with and mentor a team of engineers, providing guidance on technical challenges, process development, and best practices. Foster a culture of innovation and continuous improvement.
  • Cross-functional Collaboration: Work closely with R&D, regulatory, quality, supply chain, and manufacturing teams to ensure seamless integration of engineering requirements across all functions.
  • Product Deployment: Collaborate with the design, prototyping, and testing, and manufacturing launch of new medical devices, ensuring compliance with industry standards (e.g., ISO 13485, FDA regulations, IEC 60601).
  • Risk Management: Identify potential engineering risks early in the development and deployment process and implement mitigation plans. Lead failure mode and effects analysis (FMEA) and ensure design and manufacturing controls are followed. Direct and participate in DFx activities.
  • Regulatory & Compliance: Be familiar with medical compliance processes (IQ, OQ, PQ, etc.) Ensure all engineering deliverables and documentation are in compliance with relevant medical device regulations (FDA, ISO, CE). Support regulatory submissions and audits.
  • Technical Documentation: Develop and review technical documentation required for product approval, manufacturing, and post-market support, including design history files (DHF), risk management files, and validation reports.
  • Continuous Improvement: Promote the use of best engineering practices, tools, and processes for efficient product development. Identify and implement opportunities for process optimization.


Qualifications:

  • Education: Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related field). Master’s degree preferred.
  • Experience:
  • 5+ years of experience in product development, with at least 2-3 years in a leadership or management role.
  • Proven experience leading NPI projects for medical devices, with a strong understanding of the development lifecycle and regulatory requirements.
  • Hands-on experience with design, prototyping, and testing of medical products (electromechanical, reusable and single use devices).
  • Experience in cross-functional teams, driving product design, development, and manufacturing in a regulated environment.
  • Technical Skills:
  • Familiarity in CAD (e.g., SolidWorks, AutoCAD) and simulation tools.
  • Strong understanding of manufacturing processes (e.g., injection molding, PCB design and assembly, mechanical assembly).
  • Strong understanding of DFx principles and practices.
  • Familiarity with medical device standards (ISO 13485, IEC 60601, FDA 21 CFR Part 820).


*This position will be up to 25-50% travel*



  • saint petersburg, United States Insight Global Full time

    Insight Global is looking for an Electrical Design Engineer in St. Petersburg, FL. This person will be responsible for printed circuit board design/architecture, component selection, schematic design using Altium or OrCAD, oversee layout, create test protocols and perform board bring up as well as integrity testing. Other responsibilities may include,...


  • saint petersburg, United States Insight Global Full time

    Insight Global is looking for an Electrical Design Engineer in St. Petersburg, FL. This person will be responsible for printed circuit board design/architecture, component selection, schematic design using Altium or OrCAD, oversee layout, create test protocols and perform board bring up as well as integrity testing. Other responsibilities may include,...


  • saint petersburg, United States Insight Global Full time

    Required Skills and Experience *Bachelor’s degree in Electrical Engineering or a related field.Minimum of 8-10 years of engineering experience, ideally focusing on Value Analysis/Value Engineering (VAVE) and/or Design for Manufacturability (DFM).Experience in a leadership or managerial role within a design or manufacturing environment.Strong analytical and...


  • saint petersburg, United States Insight Global Full time

    Required Skills and Experience *Bachelor’s degree in Electrical Engineering or a related field.Minimum of 8-10 years of engineering experience, ideally focusing on Value Analysis/Value Engineering (VAVE) and/or Design for Manufacturability (DFM).Experience in a leadership or managerial role within a design or manufacturing environment.Strong analytical and...


  • St Petersburg, United States Insight Global Full time

    Position Summary:We are seeking a highly skilled and experienced Engineering Lead to join our dynamic New Product Introduction (NPI) team for medical devices. This role will be responsible for collaborating with cross-functional teams in the introduction of innovative medical products to manufacturing, ensuring adherence to regulatory standards, quality...


  • St. Petersburg, United States NSI Healthcare Full time

    Medical Assistant Saint Petersburg, FLAbout the job Medical Assistant Saint Petersburg, FLMedical Assistant Saint Petersburg, FLLocation: St. Petersburg, FLWe are a Private Family Medicine Practice that is looking for a caring and compassionate Medical Assistant.We have a warm and friendly environment in our office.We treat Adult & Children patients!Our...


  • saint petersburg, United States Insight Global Full time

    NOTE: THIS IS ONLY A 6 MONTH CONTRACT!Required Skills & Experience- Bachelor's Degree in Engineering - 10 years of experience as a systems engineer including requirements development and product definition. - 10+ years of relevant experience in medical device development - Experience managing entire design cycles from concept to productionJob...

  • NPD Project Manager

    4 weeks ago


    saint petersburg, United States Insight Global Full time

    Insight Global is looking for an NPD Project Manager to work in office in St. Petersburg, FL, with experience managing medical device (OR Aviation, Automotive, regulated electronic devices, etc.) new product development engineering. This is a long term 12-24 month long W2 contract position with possible additional extensions.Job Summary:This person will be...


  • St Petersburg, United States NSI Health Care Services Full time

    Phlebotomist Saint Petersburg, FL About the job Phlebotomist Saint Petersburg, FLPhlebotomist Saint Petersburg, FLLocation: St. Petersburg, FLWe are a Private Family Medicine Practice that is looking for a caring and compassionate Phlebotomist.We have a warm and friendly environment in our office.We treat Adult & Children patients!Our position is Full...


  • St Petersburg, United States NSI Health Care Services Full time

    Phlebotomist Saint Petersburg, FL About the job Phlebotomist Saint Petersburg, FLPhlebotomist Saint Petersburg, FLLocation: St. Petersburg, FLWe are a Private Family Medicine Practice that is looking for a caring and compassionate Phlebotomist.We have a warm and friendly environment in our office.We treat Adult & Children patients!Our position is Full...


  • saint petersburg, United States Insight Global Full time

    Job Description:10 years of experience in related field Design of high-rise multifamily buildings - preferably hotels, apartments, condos, student housing, senior living, etc.Design of commercial buildings is also ok if they have some high-rise experience as well. Offices, hospitals, medical buildings, etc.Design from start to finish of new construction EOR...


  • saint petersburg, United States Insight Global Full time

    Job Description:10 years of experience in related field Design of high-rise multifamily buildings - preferably hotels, apartments, condos, student housing, senior living, etc.Design of commercial buildings is also ok if they have some high-rise experience as well. Offices, hospitals, medical buildings, etc.Design from start to finish of new construction EOR...


  • saint petersburg, United States Insight Global Full time

    Insight Global is looking for a Embedded Firmware/Software Engineer, with experience or interest in the medical device industry. Must be willing to work in St. Petersburg, FL. This is an initial 6-9 month W2 contract with likely extensions.The Software/Firmware Design Engineer is a self-motivated engineer who designs, develops, and verifies software...


  • saint petersburg, United States Insight Global Full time

    Insight Global is looking for a Embedded Firmware/Software Engineer, with experience or interest in the medical device industry. Must be willing to work in St. Petersburg, FL. This is an initial 6-9 month W2 contract with likely extensions.The Software/Firmware Design Engineer is a self-motivated engineer who designs, develops, and verifies software...


  • St Petersburg, United States Insight Global Full time

    NOTE: THIS IS ONLY A 6 MONTH CONTRACT!Required Skills & Experience- Bachelor's Degree in Engineering - 10 years of experience as a systems engineer including requirements development and product definition. - 10+ years of relevant experience in medical device development - Experience managing entire design cycles from concept to productionJob...

  • NPD Project Manager

    4 weeks ago


    St Petersburg, United States Insight Global Full time

    Insight Global is looking for an NPD Project Manager to work in office in St. Petersburg, FL, with experience managing medical device (OR Aviation, Automotive, regulated electronic devices, etc.) new product development engineering. This is a long term 12-24 month long W2 contract position with possible additional extensions.Job Summary:This person will be...


  • St. Petersburg, United States Nirvana Healthcare Full time

    Medical Assistant Saint Petersburg FL Location: St. Petersburg FL We are a Private Family Medicine Practice that is looking for a caring and compassionate Medical Assistant. We have a warm and friendly environment in our office. We treat Adult & Children patients! Our position is Full Time! We are open: Monday Friday: 8am 5pm No Weekends! Pay: $16 ...

  • Travel Nurse RN

    4 weeks ago


    Saint Petersburg, United States Travel Nurse Across America Full time

    Travel Nurse Across America is seeking a qualified Operating room RN needed for travel nurse assignment in Saint Petersburg, FL. This assignment is in a Traveler-friendly facility and offers excellent pay, benefits, bonus opportunity, travel reimbursement, all licenses and certifications paid and more! Minimum 1-2 years’ experience required.Requirements*:...


  • saint petersburg, United States Insight Global Full time

    NOTE: THIS IS A 9 MONTH CONTRACTRequired Skills & Experience- Bachelor's Degree in Electrical Engineering - 10+ years experience in PCB design and board bring up and schematic design. - 4+ years recent power conversion design experience (specifically DC/DC). - 3+ Years experience with Altium or OrCAD design software - Working knowledge of sensors, battery...

  • NPD Project Manager

    4 weeks ago


    St Petersburg, FL, United States Insight Global Full time

    Insight Global is looking for an NPD Project Manager to work in office in St. Petersburg, FL, with experience managing medical device (OR Aviation, Automotive, regulated electronic devices, etc.) new product development engineering. This is a long term 12-24 month long W2 contract position with possible additional extensions.Job Summary:This person will be...