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Project Engineer jobs at Medical Billing

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  • Sr. Electrical Engineer/Product Engineering

    Hologic 4.4company rating

    Marlborough, MA jobs

    As a Sr. Electrical Engineer, Product Engineering, you'll maintain hardware continuity for our existing portfolio and drive design improvements that elevate quality, performance, and cost efficiency. You'll be a key stakeholder across Regulatory, Quality, Manufacturing, and external suppliers-leading and supporting multiple projects simultaneously. Your expertise will help troubleshoot hardware issues, develop robust verification strategies for design changes, and support the continuous improvement of our systems. This role will be located in Marlborough, MA and we will require 100% onsite presence. Key Responsibilities: Safeguard the lifecycle of existing products by evaluating and managing electrical component End-of-Life (EOL) across multiple PCBs and products. Lead troubleshooting efforts for electrical and electro-mechanical systems on field returns, determining root causes and implementing design changes based on quality and risk imperatives. Drive hardware design efforts for product line extensions, VIPs (Value Improving Projects), and new features for existing products. Develop electrical test fixtures and prototype boards to support testing and design improvements. Support manufacturing with process and fixture improvements for critical hardware. Collaborate with strategic sourcing partners and suppliers to implement technical cost-saving design changes and solve design challenges. Interpret and improve verification methods for electrical components, PCBs, and subsystems to ensure state-of-the-art practices. Build and maintain strong collaborative relationships with key internal and external stakeholders. Stay current with emerging technologies and processes to fuel ongoing innovation across the portfolio. Qualifications & Experience: Bachelor's or Master's in Electrical Engineering. 5+ years' experience in new product development and/or medical device industry (with Bachelor's). 3+ years' experience in new product development and/or medical device industry (with Master's). Skills & Attributes: Ability to troubleshoot and root cause failure modes in PCBs and electro-mechanical systems. Schematic-level design experience, preferably with Altium toolset. Proficiency with electrical test and development equipment (oscilloscopes, LCR meters, logic analyzers, power supplies). Foundational knowledge of DFM (Design for Manufacturing) in electrical engineering design. Experience with FPGAs, CPLDs, analog and digital circuits, microcontrollers, and power delivery circuitry. Experience designing for IEC 60601 safety and EMC compliance. Familiarity with embedded systems and ability to collaborate with hardware and software teams. Exceptional verbal, written, and presentation communication skills, with the ability to adapt for technical and non-technical audiences. Proficient in generating technical documentation, including test protocols, reports, and design descriptions. Travel: Ability to travel as necessary, up to 10%. So why join Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you. If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you!The annualized base salary range for this role is $97,600 - $152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. LI-#DS1 #onsite
    $97.6k-152.7k yearly Auto-Apply 39d ago
  • Sr. Electrical Engineer - Product Engineering - Marlborough, MA

    Hologic 4.4company rating

    Marlborough, MA jobs

    As a Sr. Electrical Engineer, Product Engineering, you'll maintain hardware continuity for our existing portfolio and drive design improvements that elevate quality, performance, and cost efficiency. You'll be a key stakeholder across Regulatory, Quality, Manufacturing, and external suppliers-leading and supporting multiple projects simultaneously. Your expertise will help troubleshoot hardware issues, develop robust verification strategies for design changes, and support the continuous improvement of our systems. This role will be located in Marlborough, MA and we will require 100% onsite presence. Key Responsibilities: * Safeguard the lifecycle of existing products by evaluating and managing electrical component End-of-Life (EOL) across multiple PCBs and products. * Lead troubleshooting efforts for electrical and electro-mechanical systems on field returns, determining root causes and implementing design changes based on quality and risk imperatives. * Drive hardware design efforts for product line extensions, VIPs (Value Improving Projects), and new features for existing products. * Develop electrical test fixtures and prototype boards to support testing and design improvements. * Support manufacturing with process and fixture improvements for critical hardware. * Collaborate with strategic sourcing partners and suppliers to implement technical cost-saving design changes and solve design challenges. * Interpret and improve verification methods for electrical components, PCBs, and subsystems to ensure state-of-the-art practices. * Build and maintain strong collaborative relationships with key internal and external stakeholders. * Stay current with emerging technologies and processes to fuel ongoing innovation across the portfolio. Qualifications & Experience: * Bachelor's or Master's in Electrical Engineering. * 5+ years' experience in new product development and/or medical device industry (with Bachelor's). * 3+ years' experience in new product development and/or medical device industry (with Master's). Skills & Attributes: * Ability to troubleshoot and root cause failure modes in PCBs and electro-mechanical systems. * Schematic-level design experience, preferably with Altium toolset. * Proficiency with electrical test and development equipment (oscilloscopes, LCR meters, logic analyzers, power supplies). * Foundational knowledge of DFM (Design for Manufacturing) in electrical engineering design. * Experience with FPGAs, CPLDs, analog and digital circuits, microcontrollers, and power delivery circuitry. * Experience designing for IEC 60601 safety and EMC compliance. * Familiarity with embedded systems and ability to collaborate with hardware and software teams. * Exceptional verbal, written, and presentation communication skills, with the ability to adapt for technical and non-technical audiences. * Proficient in generating technical documentation, including test protocols, reports, and design descriptions. Travel: Ability to travel as necessary, up to 10%. So why join Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you. If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you!The annualized base salary range for this role is $97,600 - $152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. LI-#DS1 #onsite
    $97.6k-152.7k yearly 20d ago
  • Sr. Electrical Engineer - Product Engineering - Marlborough, MA

    Hologic 4.4company rating

    Marlborough, MA jobs

    Marlborough, MA, United States As a **Sr. Electrical Engineer, Product Engineering** , you'll maintain hardware continuity for our existing portfolio and drive design improvements that elevate quality, performance, and cost efficiency. You'll be a key stakeholder across Regulatory, Quality, Manufacturing, and external suppliers-leading and supporting multiple projects simultaneously. Your expertise will help troubleshoot hardware issues, develop robust verification strategies for design changes, and support the continuous improvement of our systems. This role will be located in Marlborough, MA and we will require 100% onsite presence. **Key Responsibilities:** + Safeguard the lifecycle of existing products by evaluating and managing electrical component End-of-Life (EOL) across multiple PCBs and products. + Lead troubleshooting efforts for electrical and electro-mechanical systems on field returns, determining root causes and implementing design changes based on quality and risk imperatives. + Drive hardware design efforts for product line extensions, VIPs (Value Improving Projects), and new features for existing products. + Develop electrical test fixtures and prototype boards to support testing and design improvements. + Support manufacturing with process and fixture improvements for critical hardware. + Collaborate with strategic sourcing partners and suppliers to implement technical cost-saving design changes and solve design challenges. + Interpret and improve verification methods for electrical components, PCBs, and subsystems to ensure state-of-the-art practices. + Build and maintain strong collaborative relationships with key internal and external stakeholders. + Stay current with emerging technologies and processes to fuel ongoing innovation across the portfolio. **Qualifications & Experience:** + Bachelor's or Master's in Electrical Engineering. + 5+ years' experience in new product development and/or medical device industry (with Bachelor's). + 3+ years' experience in new product development and/or medical device industry (with Master's). **Skills & Attributes:** + Ability to troubleshoot and root cause failure modes in PCBs and electro-mechanical systems. + Schematic-level design experience, preferably with Altium toolset. + Proficiency with electrical test and development equipment (oscilloscopes, LCR meters, logic analyzers, power supplies). + Foundational knowledge of DFM (Design for Manufacturing) in electrical engineering design. + Experience with FPGAs, CPLDs, analog and digital circuits, microcontrollers, and power delivery circuitry. + Experience designing for IEC 60601 safety and EMC compliance. + Familiarity with embedded systems and ability to collaborate with hardware and software teams. + Exceptional verbal, written, and presentation communication skills, with the ability to adapt for technical and non-technical audiences. + Proficient in generating technical documentation, including test protocols, reports, and design descriptions. **Travel:** Ability to travel as necessary, up to 10%. **So why join Hologic?** We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you. If you have the right skills and experience and want to join our team, apply today. We can't wait to hear from you!The annualized base salary range for this role is $97,600 - $152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. LI-#DS1 \#onsite
    $97.6k-152.7k yearly 38d ago
  • Principal Mechanical Engineer

    Ivenix, Inc. 4.1company rating

    North Andover, MA jobs

    The Principal Mechanical Engineer is a self-starter who can play a principal role in our development team. In this role you will plan, direct and implement the designs and improvements to the mechanical systems in Ivenix products to achieve product performance goals and business objectives. This position is the technical lead for the development and ongoing support of all durable goods designed by Ivenix. Essential functions: Leads the design and development of products and/or processes relating to the mechanical architecture Design complex electro-mechanical mechanisms to achieve engineering performance goals Integrate functional elements unto a unified system design Package subsystems into a sleek, ergonomic industrial design Optimize designs for low-cost, high quality, high reliability and high-volume assembly Investigates new technologies and best practices Coordinates with engineers to establish engineering documentation. Focuses efforts around improved performance and reduced complexity Coordinates with internal and external resources to conduct design, redesign, prototype, and transfer to manufacturing activities Performs and documents failure analysis of returned product Oversees technical records and files Works with customers and vendors as needed regarding technical issues Performs other related duties as assigned Supervisory Responsibility: None Education and Experience Requirements: To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Bachelor's degree in Mechanical Engineering; an advanced degree is preferred 7+ years of experience designing mechanical systems in a regulated environment Experience designing complex electro-mechanical assemblies in SolidWorks or other CAD system. Experience using PDM to manage database and drawing revisions in accordance with FDA requirements Design for manufacturing and high reliability Experience with system integration challenges such as thermal management of electronics, injection molded part design, and design for manufacturing and reliability Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The physical demands are representative of a normal office environment. Visual perception may be come strained if working for long hours in front of computer screen. While performing the duties of this job, individuals are required to: Sit for long periods of time, as well as talk and hear Interact with physical systems and use small hand tools Working Conditions: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Working conditions are representative of a normal office environment. The noise level in the work environment is usually moderate and typical of an office environment. On average, this position requires 5% of the employee's time working to be spent travelling. On average, this position requires 10% of the employee's time working to be spent in an engineering lab, test lab, or machining environment.
    $109k-141k yearly est. Auto-Apply 60d+ ago
  • NPD R&D Engineer 2 - Marlborough, MA

    Hologic 4.4company rating

    Marlborough, MA jobs

    The Product Development Engineer 2 applies strong technical expertise and customer-centric design principles to support new product development from concept through production. This role requires the ability to work both independently and collaboratively to solve moderately complex engineering challenges, contribute to project documentation, and support manufacturing transfer activities. Required Knowledge: In-depth understanding of engineering principles and practices relevant to biomedical or mechanical product development, particularly in the medical device industry. Knowledge of manufacturing processes such as machining, injection molding, rapid prototyping, and common joining methods. Familiarity with risk management tools, including the identification, assessment, and mitigation of risks throughout the product lifecycle. Understanding of design for manufacturability (DFM), geometric dimensioning and tolerancing (GD&T), and tolerance stack-ups. Proficiency in using CAD software; SolidWorks experience preferred. Awareness of experimental, computational, and analytical tools such as DFSS, statistical methods (DOE), and MiniTab. Required Skills: Ability to independently execute simple to moderately complex design and project tasks with attention to detail and quality. Strong technical problem-solving skills, with the capacity to formulate and resolve engineering challenges using sound technical judgment. Excellent technical writing skills, including the ability to prepare engineering reports, protocols, and validation documentation. Effective verbal and written communication abilities to interact with cross-functional teams, suppliers, customers, and contractors. Action-oriented with a drive for results and the ability to learn new technical concepts quickly. Competence in evaluating, selecting, and applying standard engineering techniques and procedures to project tasks. Required Behaviors: Customer-focused mindset, ensuring design solutions meet user needs and regulatory requirements. Collaborative team player, able to work effectively in multidisciplinary project teams. Proactive approach to learning and expanding technical skills across different areas. Adaptability, with the ability to receive and incorporate feedback and supervision appropriately. Detail-oriented and organized, capable of managing multiple tasks and priorities. Commitment to ethical practices, safety, and compliance standards. Required Experience: Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field, with at least 2 years of relevant experience in research and development within the medical device industry, or Master's degree in a relevant field with 0-2 years of experience in health and/or business communities. Demonstrated experience supporting product development, from concept through to production and manufacturing transfer. Exposure to regulatory and quality requirements within the medical device industry is advantageous. Work Environment and Physical Requirements: Regularly required to sit, stand, walk, reach, handle objects, talk, and hear. Must possess close vision, color vision, and the ability to adjust focus. Ability to lift or move up to 25 pounds and work flexible hours as needed. Willingness to travel up to 10% as required. So why join Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you. The annualized base salary range for this role is 76,800-120,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. LI-#LB2
    $82k-106k yearly est. Auto-Apply 7d ago
  • NPD R&D Engineer 2 - Marlborough, MA

    Hologic 4.4company rating

    Marlborough, MA jobs

    Marlborough, MA, United States The Product Development Engineer 2 applies strong technical expertise and customer-centric design principles to support new product development from concept through production. This role requires the ability to work both independently and collaboratively to solve moderately complex engineering challenges, contribute to project documentation, and support manufacturing transfer activities. **Required Knowledge:** + In-depth understanding of engineering principles and practices relevant to biomedical or mechanical product development, particularly in the medical device industry. + Knowledge of manufacturing processes such as machining, injection molding, rapid prototyping, and common joining methods. + Familiarity with risk management tools, including the identification, assessment, and mitigation of risks throughout the product lifecycle. + Understanding of design for manufacturability (DFM), geometric dimensioning and tolerancing (GD&T), and tolerance stack-ups. + Proficiency in using CAD software; SolidWorks experience preferred. + Awareness of experimental, computational, and analytical tools such as DFSS, statistical methods (DOE), and MiniTab. **Required Skills:** + Ability to independently execute simple to moderately complex design and project tasks with attention to detail and quality. + Strong technical problem-solving skills, with the capacity to formulate and resolve engineering challenges using sound technical judgment. + Excellent technical writing skills, including the ability to prepare engineering reports, protocols, and validation documentation. + Effective verbal and written communication abilities to interact with cross-functional teams, suppliers, customers, and contractors. + Action-oriented with a drive for results and the ability to learn new technical concepts quickly. + Competence in evaluating, selecting, and applying standard engineering techniques and procedures to project tasks. **Required Behaviors:** + Customer-focused mindset, ensuring design solutions meet user needs and regulatory requirements. + Collaborative team player, able to work effectively in multidisciplinary project teams. + Proactive approach to learning and expanding technical skills across different areas. + Adaptability, with the ability to receive and incorporate feedback and supervision appropriately. + Detail-oriented and organized, capable of managing multiple tasks and priorities. + Commitment to ethical practices, safety, and compliance standards. **Required Experience:** + Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field, with at least 2 years of relevant experience in research and development within the medical device industry, or + Master's degree in a relevant field with 0-2 years of experience in health and/or business communities. + Demonstrated experience supporting product development, from concept through to production and manufacturing transfer. + Exposure to regulatory and quality requirements within the medical device industry is advantageous. **Work Environment and Physical Requirements:** + Regularly required to sit, stand, walk, reach, handle objects, talk, and hear. + Must possess close vision, color vision, and the ability to adjust focus. + Ability to lift or move up to 25 pounds and work flexible hours as needed. + Willingness to travel up to 10% as required. **So why join Hologic?** We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you. The annualized base salary range for this role is 76,800-120,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. LI-#LB2
    $82k-106k yearly est. 6d ago
  • Lead Product Security Engineer (R&D Cytology)

    Hologic 4.4company rating

    Marlborough, MA jobs

    Marlborough, MA, United States San Diego, CA, United States Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day. Our Software Engineering (R&D) department in our Diagnostics division is looking for a Security Engineer experienced in medical device and/or instruments security and systems to join our team, pivotal in building and enhancing security in our products and services! As a **Lead Product Security Engineer** and the SME for our Cytology R&D team, you will the key cybersecurity representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a hybrid role based out of either Marlborough, MA or San Diego, CA. **Key responsibilities and applied experience required from a candidate:** + Maintain vigilance on industry security threats, assess risks to Hologic products, and manage these risks according to established quality procedures. + Participate in continuous improvement of our Secure by Design principles and implementation, ensuring adherence to security standards and best practices. + Support the creation and maintenance of security design documentation and architecture diagrams. + Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory, Quality) to integrate security into the product lifecycle. + Define security requirements and controls based on specific use cases and threat models. + Perform regular risk analyses to evaluate security threats and vulnerabilities, prioritizing uncontrolled risks with potential impacts on patient safety. + Perform Security Risk Management activities to address identified vulnerabilities and security design issues, including regular review and assessment of risk against CVEs. + Establish automated processes for vulnerability scanning and remediation + Educate the development and leadership teams on securing products, remote connectivity solutions, and their operating environments. + Work with cross-functional teams to ensure that SBOMs are correct and can be used as part of our continuous vulnerability monitoring process + Design architecture that prioritizes efficient, secure software updates and patch management across deployed systems. + Establish incident playbooks and coordinate root cause analysis (RCA) for reported security incidents. + Work with DevSecOps and Software Engineers to review code static analysis and third-party software assessment reports. **Experiences that are nice to have:** + Collaborate with Program Management and Regulatory teams to provide security input for audits and FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, IEC, NIST, AAMI, CSLI, UL, BSI, HIPAA, + GDPR, State and Federal security standards, and ACTS for premarket and post-market activities. + Assist in translating cybersecurity requirements into product requirements for new and existing product designs, as well as assisting with the definition of verifications for traceability. + Assist with efforts to establish penetration testing suites for continuous testing and monitoring of our product solution. **Minimum Requirements:** + Bachelor's or Master's degree in Computer Science, Cybersecurity, or related engineering equivalent. + Minimum of 8 - 12 years of professional experience in product security/cybersecurity engineering + Demonstrated competency in Cybersecurity education and training through certifications (e.g., CISSP, CompTIA Security+, etc.) + Strong interpersonal skills, with the ability to communicate cybersecurity concepts to a variety of audiences. + Skilled in working within cross-functional groups. + Skilled in performing Risk Assessment and Management plan + Skilled in writing design documentation and standard operating procedures. + Experience working in an FDA regulated environment is required. + Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities. + Strong verbal & written communication skills. + Familiarity with Windows OS and cloud-based solutions is required + Expertise with security frameworks and testing tools, and how to incorporate the results of those into cybersecurity requirements for the Product Development team. + Proficiency in scripting and simple test automation (e.g., PowerShell, Python). The annualized base salary range for this role is $131,500 to $205,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand. **Why Hologic?** We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. If you have the right skills and experience, **apply today!** \#LI-RF1 #lead-level Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
    $131.5k-205.8k yearly 60d+ ago
  • Lead Product Security Engineer (R&D Cytology)

    Hologic 4.4company rating

    Marlborough, MA jobs

    Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day. Our Software Engineering (R&D) department in our Diagnostics division is looking for a Security Engineer experienced in medical device and/or instruments security and systems to join our team, pivotal in building and enhancing security in our products and services! As a Lead Product Security Engineer and the SME for our Cytology R&D team, you will the key cybersecurity representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a hybrid role based out of either Marlborough, MA or San Diego, CA. Key responsibilities and applied experience required from a candidate: Maintain vigilance on industry security threats, assess risks to Hologic products, and manage these risks according to established quality procedures. Participate in continuous improvement of our Secure by Design principles and implementation, ensuring adherence to security standards and best practices. Support the creation and maintenance of security design documentation and architecture diagrams. Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory, Quality) to integrate security into the product lifecycle. Define security requirements and controls based on specific use cases and threat models. Perform regular risk analyses to evaluate security threats and vulnerabilities, prioritizing uncontrolled risks with potential impacts on patient safety. Perform Security Risk Management activities to address identified vulnerabilities and security design issues, including regular review and assessment of risk against CVEs. Establish automated processes for vulnerability scanning and remediation Educate the development and leadership teams on securing products, remote connectivity solutions, and their operating environments. Work with cross-functional teams to ensure that SBOMs are correct and can be used as part of our continuous vulnerability monitoring process Design architecture that prioritizes efficient, secure software updates and patch management across deployed systems. Establish incident playbooks and coordinate root cause analysis (RCA) for reported security incidents. Work with DevSecOps and Software Engineers to review code static analysis and third-party software assessment reports. Experiences that are nice to have: Collaborate with Program Management and Regulatory teams to provide security input for audits and FDA submissions. Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, IEC, NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities. Assist in translating cybersecurity requirements into product requirements for new and existing product designs, as well as assisting with the definition of verifications for traceability. Assist with efforts to establish penetration testing suites for continuous testing and monitoring of our product solution. Minimum Requirements: Bachelor's or Master's degree in Computer Science, Cybersecurity, or related engineering equivalent. Minimum of 8 - 12 years of professional experience in product security/cybersecurity engineering Demonstrated competency in Cybersecurity education and training through certifications (e.g., CISSP, CompTIA Security+, etc.) Strong interpersonal skills, with the ability to communicate cybersecurity concepts to a variety of audiences. Skilled in working within cross-functional groups. Skilled in performing Risk Assessment and Management plan Skilled in writing design documentation and standard operating procedures. Experience working in an FDA regulated environment is required. Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST, AAMI, CSLI, UL, BSI, HIPAA, GDPR, State and Federal security standards, and ACTS for premarket and post-market activities. Strong verbal & written communication skills. Familiarity with Windows OS and cloud-based solutions is required Expertise with security frameworks and testing tools, and how to incorporate the results of those into cybersecurity requirements for the Product Development team. Proficiency in scripting and simple test automation (e.g., PowerShell, Python). The annualized base salary range for this role is $131,500 to $205,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand. Why Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. If you have the right skills and experience, apply today! #LI-RF1 #lead-level Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
    $131.5k-205.8k yearly Auto-Apply 60d+ ago
  • Hardware Engineering Project Manager II

    Whoop 4.0company rating

    Boston, MA jobs

    At WHOOP, we're on a mission to unlock human performance. WHOOP empowers members to perform at a higher level through a deeper understanding of their bodies and daily lives. WHOOP is seeking a Hardware Engineering Project Manager II to drive the execution of hardware initiatives that enhance our member experience and product performance. This role will lead cross-functional projects that span continuous improvement efforts, yield enhancements, and full electromechanical redesigns. You will play a vital role in scaling innovation from concept to deployment in collaboration with engineering, manufacturing, firmware, and supply chain teams.RESPONSIBILITIES: Lead hardware engineering projects from kickoff through launch, focusing on performance, cost, and quality improvements Create and manage detailed project plans aligned with WHOOP goals, balancing timelines, resources, and risk mitigation Coordinate engineering builds and iterative development activities with internal and external manufacturing partners Facilitate effective cross-functional collaboration and communication, ensuring timely decision-making and alignment Proactively identify and manage project risks and dependencies, driving resolution of technical and organizational blockers Contribute to the ongoing refinement of WHOOP's Continuous Improvement Engineering process to enhance project execution and reliability QUALIFICATIONS: Bachelor's degree in Engineering or equivalent practical experience in hardware product development 3+ years of industry experience in the area of consumer electronic product development Demonstrated success managing cross-functional hardware projects from development through launch Strong understanding of product component development cycles, lead times, and sourcing processes Experience communicating with Engineering, Manufacturing, and external partners both domestically and internationally Innovative, knowledgeable, and able to adapt to fast-paced changing requirements Excellent written and verbal communication skills, with a track record of effective stakeholder management WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office. The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success. The U.S. base salary range for this full-time position is $110,000 - $150,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training. In addition to the base salary, the successful candidate will also receive benefits and a generous equity package. These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate's specific qualifications, expertise, and alignment with the role's requirements. Learn more about WHOOP.
    $110k-150k yearly Auto-Apply 60d+ ago
  • Plant Engineer II

    Organogenesis, Inc. 4.8company rating

    Canton, MA jobs

    About Us We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing. Our advanced wound care products are specially developed for the successful treatment of chronic and acute wounds. Our comprehensive portfolio of skin substitutes and other regenerative medicine products empower our patients with life-changing solutions. Our strength is giving others strength. Learn more about Careers at Organogenesis What You Will Achieve: The Plant Engineer is responsible for supporting maintenance and operations at a GMP facility to support manufacturing activities in a cGMP environment to meet user needs and QA compliance requirements. The Plant Engineer will support the Facilities department with maintenance, operations, and projects. The Plant Engineer will support the on-call facilities tech as needed to support 24/7 manufacturing operations. The hours for this position are Wednesday-Saturday 1:00 pm-11:30 pm. The hours during training (up to 4 month) will be Monday-Friday 8:30 am-5:00 pm How You Will Achieve It: * Manages HVAC system maintenance and operations * Manages control temperature rooms (Cold and Warm Rooms) maintenance and operation * Supports maintenance and repair of clean utilities (Autoclaves, Water systems, Clean Steam, and Glass Washers) * Supports the team by occasionally being a part of the On-Call Rotation. * Facilities Subject Matter Expert (SME) for document review and capital projects * Own change controls and drive to closure in a timely manner, ensure RAM (CMMS) data base modifications are properly completed for new equipment and changes to systems. * Executes small facilities maintenance projects. * Develops PM procedures. * Verify system drawings are accurate. * Responsible for critical spare parts inventory * Ensures their work meets QA compliance requirements, that all tasks are completed on schedule, and problems are resolved in an efficient and effective manner. * Develops specifications and procedures for the Maintenance operations. * Responsible for special projects as directed by supervisor. * Performs all other duties as assigned. Job Requirements What You Need to Achieve It: * 4-year degree college degree majoring in engineering or technical discipline and 2-5 years' experience or equivalent facilities or construction experience. * Previous experience in medical device, biotech, or R & D facilities preferred. * This position requires excel organizational skills, ability to manage multiple tasks concurrently, and excellent verbal and written communication skills. * cGMP knowledge required. * Ability to work with other Facilities groups and other departments to problem solve issues. Strong collaboration abilities. * Self-starter who can perform tasks with minimal supervision. * Computer literate with Microsoft products such as Excel, Word, Power Point * Problem solving skills. * Ability to work cross functionally across all Organogenesis departments. * Ability to support off hours work and on call technicians 24/7. Physical Demands * Approximately 6 hours per day of standing. * Ability to climb into and crawl through a low clearance mezzanine. * Ability to climb a ladder to the roof. Environmental Conditions * Occasionally around loud noises * Occasionally in outdoor weather extremes of High Humidity during the summer and out in the snow in the winter around mechanical and utility equipment. What can we offer you? * 401k -- generous employer match with immediate vesting and financial planning resources * Comprehensive Medical, Dental and Vision coverage options effective on day one of employment * Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account * Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options * Paid maternity leave and parental leave for all new parents * Adoption benefits * Education Assistance Policy - $5,000 per year for all employees * Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more * Employee Assistance Program * Generous paid time off including vacation, floating holidays, sick days, and company holidays * Free parking including an electric charging station (Canton and La Jolla) * Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint The anticipated annualized base salary for this role is $79,500 - $99,500 and reflects current market data for similarly-sized life science companies and internal equity. Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law. We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law. We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes. Physical Required Job Type Full-time Location Organogenesis Inc. Headquarters Shipping Address/Apligraf Manufacturing - Canton, MA 02021 US (Primary) Education Bachelor's Degree Career Level Individual Contributor Travel
    $79.5k-99.5k yearly 34d ago
  • Workday Intake and Demand Project Manager

    Massachusetts Eye and Ear Infirmary 4.4company rating

    Somerville, MA jobs

    Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary MGB Digital Workday Governance is hiring a Workday Intake and Demand Project Manager! The Opportunity Responsible for managing enterprise-wide Digital/IT project. Provides project management guidance to project coordinators and other project managers on the team. -Develop project goals, objectives, approach, and scope through negotiation and diplomacy that result in a well-defined, well-sponsored project. -Negotiate and acquire the enterprise-wide resources necessary to appropriately implement the project. -Develop workplans and timelines to meet project goals. -Contribute to development of Digital/IT solutions that align with Digital standards and strategic directions. -Develop capital and operating funding requirements associated with a project. -Manage a project within its budget. -Plan, manage and oversee projects, using recognized project management methods. -Manage projects within the context of the larger environment including competing priorities, staffing levels, and budgetary concerns. -Provide appropriate and timely problem escalation (including potential solutions where applicable) to both Digital management, project steering committees, and executive management. -Provide guidance and mentorship to other project managers and coordinators. Qualifications Skills and Qualifications for Success Bachelor's Degree Computer Applications required or Bachelor's Degree Related MGB can consider and review experience in lieu of a degree Information Technology Experience 5-7 years required Ability to manage large, complex projects, including their dependencies, team members, other resources, and timeline. Ability to prioritize and delegate project demands accordingly. Exceptional written and verbal communication and presentation skills. Exceptional analytic and problem-solving skills. Ability to work with people cooperatively and effectively from all organizational levels and build consensus through negotiation and diplomacy. Ability to facilitate and work within a complex, multi-site environment. Additional Job Details (if applicable) Working Model Requirements M-F Eastern Business Hours Hybrid working model includes onsite work in office as scheduled for team and business needs weekly Remote workdays require stable, secure, quiet, compliant workstation using MGB provided equipment Remote Type Hybrid Work Location 399 Revolution Drive Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $92,102.40 - $134,056.00/Annual Grade 7 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $92.1k-134.1k yearly Auto-Apply 13d ago
  • Project Manager II

    Massachusetts Eye and Ear Infirmary 4.4company rating

    Somerville, MA jobs

    Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Responsible for managing multiple large-scale projects within an assigned functional area or across various entities. Takes ownership of the overall project lifecycle by guiding teams and staff, facilitating communication between stakeholders, and monitoring progress toward project goals. Ensures that the project is completed successfully and provides support to team members and stakeholders as they complete essential tasks. Leads and provides guidance and support to project team members. Essential Functions: -Develops comprehensive project plans and monitors and manages projects from initiation through completion. -Secures required resources and uses formal processes and tools to manage resources, budgets, risks, and changes. -Manages projects to ensure on-time completion according to specifications and within budgeted costs. -Communicates regularly on project status with project stakeholders. -Owns project plans for multiple large-scale projects. -Provides guidance to project coordinators and project managers. -Identifies potential risks early, analyzes the possible impact, and develops mitigation strategies. Qualifications Education Bachelor's Degree Related Field of Study required. Relevant experience may be accepted in lieu of degree Master's Degree Related Field of Study preferred Experience Project management experience 5-7 years required Team leadership experience 0-1 year required Knowledge, Skills and Abilities Proven project management skills, including the ability to plan, organize, and execute projects effectively. Ability to collaborate effectively with healthcare professionals across multiple disciplines and experiences. Excellent communication skills, both written and verbal, with the ability to communicate complex technical concepts to non-technical stakeholders. Ability to adapt to a fast-paced environment and manage multiple projects simultaneously. Working Schedule: Majority of project work will be managed remotely Occasional travel to all MGB sites based on projects assigned Optional office space available at Assembly Row in Somerville, MA Remote hours require a quiet, secure, HIPAA-compliant workstation Additional Job Details (if applicable) Remote Type Hybrid Work Location 399 Revolution Drive Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $78,000.00 - $113,453.60/Annual Grade 7 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $78k-113.5k yearly Auto-Apply 10d ago
  • Sustaining Manufacturing Engineer

    Infraredx, Inc. 3.8company rating

    Bedford, MA jobs

    Responsibilities: Provides support to the Manufacturing organization to facilitate efficient operations within the production area to ensure that production goals are met. Troubleshoot current design and process challenges, determine root cause, and implement robust solutions . Support the Improvement of manufacturing procedures, inspections and test equipment necessary to improve the capabilities manufacturing. Implement process documentation changes and train direct labor personnel. Author and execute test protocols to validate manufacturing processes and equipment. Use Lean manufacturing methods and identify improvements to reduce costs, increase yields, and ensure product quality. Collaborate with contract manufacturing sites to improve product quality and achieve company goals. Assist in maintaining systems for regulatory compliance. Design, install and troubleshoot manufacturing equipment. Monitor performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Work with cross-functional groups including Product Development and Quality Engineering to analyze and disposition non-conforming products. Implement process and design changes to improve ergonomic issues as well as integrating products into Lean Manufacturing. Requirements: Strong communication and interpersonal skills. Bachelor of Science Degree in mechanical, electrical, or manufacturing engineering. Minimum of 1-3 years' experience in medical device manufacturing Experience supporting manufacturing process development, validations and qualifications Proficient understanding of analog/digital electronics. Proficiency with a variety of test equipment to include digital meters and power supplies. Proficiency with Microsoft Office applications and Solidworks Ability to interact with client companies (customer focused) and co-workers in a professional manner. Willingness to support other functions as needed, in areas such as quality and design. Willingness to travel to vendors and customer sites as needed (10% travel) Preferred: Knowledge of QSR and ISO 13485 requirements for Medical Devices. Experience with Minitab, Statgraphics, Matlab, or Python Knowledge of Lean methods
    $75k-97k yearly est. Auto-Apply 60d+ ago
  • Sustaining Manufacturing Engineer

    Infraredx, Inc. 3.8company rating

    Bedford, MA jobs

    Sustaining Manufacturing Engineer Responsibilities: Provides support to the Manufacturing organization to facilitate efficient operations within the production area to ensure that production goals are met. Troubleshoot current design and process challenges, determine root cause, and implement robust solutions. Support the Improvement of manufacturing procedures, inspections and test equipment necessary to improve the capabilities manufacturing. Implement process documentation changes and train direct labor personnel. Author and execute test protocols to validate manufacturing processes and equipment. Use Lean manufacturing methods and identify improvements to reduce costs, increase yields, and ensure product quality. Collaborate with contract manufacturing sites to improve product quality and achieve company goals. Assist in maintaining systems for regulatory compliance. Design, install and troubleshoot manufacturing equipment. Monitor performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Work with cross-functional groups including Product Development and Quality Engineering to analyze and disposition non-conforming products. Implement process and design changes to improve ergonomic issues as well as integrating products into Lean Manufacturing. Requirements: Strong communication and interpersonal skills. Bachelor of Science Degree in mechanical, electrical, or manufacturing engineering. Minimum of 1-3 years' experience in medical device manufacturing Experience supporting manufacturing process development, validations and qualifications Proficient understanding of analog/digital electronics. Proficiency with a variety of test equipment to include digital meters and power supplies. Proficiency with Microsoft Office applications and Solidworks Ability to interact with client companies (customer focused) and co-workers in a professional manner. Willingness to support other functions as needed, in areas such as quality and design. Willingness to travel to vendors and customer sites as needed (10% travel) Preferred: Knowledge of QSR and ISO 13485 requirements for Medical Devices. Experience with Minitab, Statgraphics, Matlab, or Python Knowledge of Lean methods
    $75k-97k yearly est. Auto-Apply 60d+ ago
  • Medical Affairs Project Manager

    Massachusetts Eye and Ear Infirmary 4.4company rating

    Somerville, MA jobs

    Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Under the direction of the OCMO Administrative Director, Medical Affairs, the Project Manager for Medical Affairs will be responsible for project managing the planning and day to day activities related to the design and implementation of a system-wide medical professional practice evaluation and performance management program. The individual in this role will work collaboratively with administrative and medical leadership across Mass General Brigham clinical departments, with enterprise and site-based partners within the OCMO team, and with other key stakeholders across the system. This position requires strong project management, communication and analytical skills and will provide an opportunity to contribute to the development of a robust, proactive, and systematic approach to clinician excellence. Principal Duties and Responsibilities: - Manage activities related to the development and maintenance of a system-wide medical professional practice evaluation program, including but not limited to Ongoing Professional Practice Evaluation (OPPE), focused professionalism performance evaluation, (FPPE) and re-credentialing and re-privileging process. - In partnership with medical leadership and other administrative team members, support development, vetting, and approval of rigorous system-wide and departmental quality measures through a robust committee oversight process. - Under guidance of the Administrative Director of Medical Affairs, support development of processes for design, approval, and monitoring of OPPE standards across clinical departments, and help coordinate ongoing process maintenance following system implementation. - Activities may include but are not limited to: - Serve as a central resource and key contact for specific departments and/or sites for all issues related to a system-wide medical professional practice evaluation and performance management program (MGB Provider Minimum Performance Standards) - Oversee the development of new centralized measures and reporting, including data tools and implementation. - Serve as a central resource for specific tools used to provide data to inform OPPE measures, such as the On-Line Peer Chart Review tool and Pulse360. - Partner with Digital, Data Analytics and other colleagues to support design and integration of specific OPPE measures into systems for tracking and monitoring. - Responsible for ongoing communication with departmental Quality Leaders and Administrative leaders to ensure program standards are met. - Review departmental plans to assess the efficacy of measures as an accurate reflection of provider performance on quality and safety of patient care and meet regulatory requirements. - Produce and distribute standard reports for specific departments; review report integrity as part of quality control; summarize report results. - Evaluate data and reports to assess if reporting structure meets end user requirements. - Lead, conduct, and evaluate the annual audit of specific departmental OPPE plans. - Maintain program forms and materials. - Manage contact list of key administrators and physicians for routine distributions. - Communicate with sites and relevant stakeholders, such as Compliance, the Central Credentialing Office, Digital. - Manage additional OCMO Medical Affairs projects as needed Qualifications Education Bachelor's Degree Related Field of Study or equivalent years of experience required. Master's degree in public health, healthcare management or related field strongly preferred. Demonstrated ability to work independently with a minimum amount of supervision. Demonstrated experience in project management. Demonstrated expertise in managing working relationships in a matrix structure. Experience in promoting healthcare provider behavior change is desirable. Skills, Abilities and Competencies Exceptional organizational skills and attention to detail to accomplish critical tasks and understand the impact of results on departments, current systems, and the organization as a whole. Strong organizational and analytical skills. Demonstrated ability to identify problems and follow problem through until resolution. Excellent interpersonal/communications skills. Must be able to work independently and exercise appropriate judgment as necessary. Ability to interact with individuals at all levels of the organization. Ability to assess all assigned work and manage time appropriately to meet deadlines. Must be able to juggle multiple priorities and programs effectively. Enjoy and thrive in a fast-paced environment. Proficiency with Microsoft applications (Outlook, Word, PowerPoint, Excel) required. Experience Project management experience 2-3 years required Preferred: 3-5 years relevant experience required with demonstrated competency in an complex medical center or similar environment. Demonstrated ability to work independently with a minimum amount of supervision. Demonstrated experience in project management. Demonstrated expertise in managing working relationships in a matrix structure. Experience in promoting healthcare provider behavior change is desirable. Additional Job Details (if applicable) Remote Type Hybrid Work Location 399 Revolution Drive Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $62,400.00 - $90,750.40/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $62.4k-90.8k yearly Auto-Apply 14d ago
  • Project Manager

    Massachusetts Eye and Ear Infirmary 4.4company rating

    Boston, MA jobs

    Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Summary This project manager will work closely with the PI overseeing multiple projects, including a large industry-funded project. The project manager will be responsible for aspects of project administration, planning and implementing study protocols directly with the PI, overseeing several staff member on these projects, and participating in other study aspects. The project manager will work very independently. The project manager will also coordinate and carry out study-related activities such as designing data collection instruments and programming study databases, organizing and maintaining various meetings/agendas, assisting with hiring and training of new staff, as well as creating, managing, and maintaining several internal review board protocols. Principal Duties and Responsibilities Essential Functions -Develops comprehensive project plans, monitors and manages projects from initiation through completion. -Secures required resources and uses formal processes and tools to manage resources, budgets, risks, and changes. -Manages projects to ensure on-time completion according to specifications and within budgeted costs. -Communicates regularly on project status with project stakeholders. -Owns project plans for medium to large-scale projects. -Provides guidance to project coordinators. -Identifies potential risks early, analyzes the possible impact, and develops mitigation strategies. Qualifications Education Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials Experience Project management experience 2-3 years required Knowledge, Skills and Abilities - Strong knowledge of project management tools and methodologies. - Excellent presentation skills, with the ability to communicate complex concepts in a clear and engaging manner. - Proficiency in project management software. - Strong analytical and problem-solving abilities. Additional Job Details (if applicable) Remote Type Onsite Work Location 60 Fenwood Road Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $62,400.00 - $90,750.40/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 2200 The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $62.4k-90.8k yearly Auto-Apply 6d ago
  • Project Manager - Industrial Water Solutions

    Freudenberg Group 4.3company rating

    Worcester, MA jobs

    * Project Leadership: Manage projects from start to finish - from kick-off to commissioning and hand-over - ensuring smooth communication with clients and internal teams. * Budget Control: Keep projects on track financially and timewise, monitor performance, and handle contract variations to benefit the company. * Team Coordination: Lead and allocate resources across multidisciplinary teams, including engineering, design, and commissioning experts. * Client Interaction: Engage directly with customers on-site and in the office, supporting commercial discussions and building strong relationships. * Compliance & Safety: Prepare health and safety plans, ensure adherence to statutory regulations, and maintain high standards throughout project execution. * Continuous Improvement: Drive cost-saving initiatives and efficiency programs within the project delivery team. * Site Presence: Be hands-on during commissioning phases, visiting sites as needed to supervise and support operations. * Qualificationsarrow_right * Industry Experience: Minimum 5 years in contracting, ideally within the water or wastewater treatment sector - ready to hit the ground running. * Technical Knowledge: Familiar with physical, chemical, and biological treatment systems; experience with MBR, UF, and RO technologies is a plus. Experience of project delivery with extensive electrical and software deliverables would be especially beneficial. * Commercial Skills: Confident in budget management and commercial negotiations with clients and suppliers. * Software Proficiency: Comfortable using civil engineering software and tools like MS Project, Sage, and Microsoft Office. * Flexibility: Willing to work 2-3 days in the office and travel to customer sites to support project delivery. * Team Player: Hands-on approach with strong leadership and coordination skills for managing multidisciplinary teams. * Problem-Solving: Ability to develop contingency plans and adapt to changing project demands. The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.#LI-JK3
    $86k-125k yearly est. 38d ago
  • Project Manager (Clinical Trials)

    Whoop 4.0company rating

    Boston, MA jobs

    WHOOP is an advanced health and fitness wearable, on a mission to unlock human performance and healthspan. WHOOP empowers its members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives. As the Project Manager, Clinical Trials, you will play a key role in supporting the execution of WHOOP-sponsored clinical studies. You will manage day-to-day project operations, including study timelines, budgets, regulatory submissions, and cross-functional coordination. Your role will ensure studies are executed with compliance, quality, and operational excellence while contributing to WHOOP's mission to validate digital biomarkers and support regulatory pathways for novel health applications. You will collaborate closely with internal stakeholders, external partners, and study sites to ensure smooth study startup, monitoring, and close-out. Your expertise in project management will enable you to track deliverables, identify risks, and support the development of critical study documentation and SOPs.RESPONSIBILITIES: Oversee timelines, budgets, milestones, and deliverables for multiple WHOOP-sponsored studies; provide regular updates to leadership and external stakeholders. Lead daily or bi-weekly standups with cross-functional teams and manage task delegation and workload distribution across internal team members and vendors. Support study design, startup, monitoring, and close-out, including IRB submissions, Kick Off Meetings, documentation deliverables, and status tracking. Support the preparation, review, and approval of study protocols, informed consent forms, study plans, and other key documents. Collaborate with CROs, academic partners, and research sites to ensure smooth execution and high-quality data capture. Ensure adherence to GCP, ICH, FDA, and other applicable requirements; draft and finalize project management SOPs and templates for clinical trials. Identify project risks, propose mitigation strategies, and maintain proactive communication with stakeholders. Gather agenda items, lead meetings, and oversee meeting notes and follow-up actions across the Digital Health team. QUALIFICATIONS: Bachelor's degree in Life Sciences, Public Health, Nursing, or related field. 2-3 years of experience in clinical research project management, preferably in medical devices, software as a medical device, or digital health. Ability to manage and track 2-3 projects simultaneously. Strong knowledge of GCP, ICH, FDA, and related regulatory guidelines including ISO 14155. Excellent organizational, problem-solving, and communication skills with the ability to manage multiple stakeholders across technical and scientific domains. Proficiency with project management tools such as Jira, Confluence, Google Sheets, and Box. Passion for health, wellness, and WHOOP's mission. Experience with wearable devices, digital biomarkers, or remote clinical trial designs preferred. Familiarity with data-driven health technologies or regulated medical devices preferred. PMP or equivalent project management certification (preferred but not required). This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office. Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply. WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success. The U.S. base salary range for this full-time position is $75,000 - $110,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training. In addition to the base salary, the successful candidate will also receive benefits and a generous equity package.. These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate's specific qualifications, expertise, and alignment with the role's requirements. Learn more about WHOOP .
    $75k-110k yearly Auto-Apply 60d+ ago
  • Manufacturing Engineer

    Berkshire Sterile Manufacturing LLC 3.7company rating

    Lee, MA jobs

    This person will be responsible for managing process improvements, troubleshooting, and developing corrective and preventative actions. Coordinating, evaluating, and leading engineering projects in the manufacturing facility, with special emphasis on equipment evaluations and implementing solutions using engineering principles, advanced machinery and automation technologies and making recommendations for revision and standardizing of equipment. The goal is to deliver efficient, safe, high quality production output while minimizing unplanned downtime and waste. General Expectations and Supervisory Responsibilities Coordinates and leads Process Improvement projects which pertain to all phases of the sterile fill manufacturing process. Highly organized, self-motivated and independent worker with strong skills in change, problem solving, communication, customer orientation, team skills and quality. Identify, design and implement manufacturing aids (fixtures, jigs, tools, etc.) to reduce manufacturing costs associated with direct labor, scrap and rework. Minimize quality issues and evaluate results; develop and improve manufacturing processes to meet customer and product requirements, introduce products into the production areas and follow products through the entire Manufacture, test, pack and ship process Lead and participating in multiple projects and project teams in the investigation, problem analysis, alternative evaluation and implementation of permanent solutions to chronic issues using data based solutions such as the use of lean problem solving techniques. Provide equipment technical assistance to operations personnel. Bring Best-in-Class techniques, procedures, processes and know-how into the plant operations: equipment, facilities, production processes with focus on analytical solutions. Maintain expertise on equipment with multiple degrees of freedom, manufacturing technology changes, and core process technologies Support daily activities in Operations through staffing and flexible hours; remain on-call for critical operations Work with manufacturing management to identify key areas of equipment and process improvement, then lead the implementation of these changes Support validation activities including equipment validation through collaboration on protocols and aid in execution Lead problem solving and investigations related to filling operations Collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Maintenance, Engineering, among others, to develop and maintain processes that meet cGMP and business requirements. Provide construction management oversight for ongoing capital projects Oversee contractors and service providers Troubleshoot, repair and ensure PM functions are performed on equipment and building components as required and in compliance with all regulatory requirements, including maintaining records and reports Utilize technical knowledge to assist in determining root cause of equipment or system failure and facilitate corrective actions Prepare and receive work orders as required for repairs and PM contracts with vendors Provide after-hours call-in support for production and utility outages, equipment breakdown and emergency events Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state and federal regulations, or otherwise as applicable Maintain a detailed and comprehensive understanding of USP, FDA, EU Annex 1, and other regulatory agency requirements Maintain qualification on filling operations by successful media fill simulation Experience Five plus (5+) years' experience in aseptic processing, terminal sterilization or lyophilization desired In the absence of above, 5+ years of demonstrated excellence in related technical field, i.e. performing research, technical or field work utilizing scientific or industrial equipment. Education Bachelor's degree in Industrial, Chemical, Manufacturing, or Mechanical Engineering from an accredited college or university Equivalent experience may be substituted for educational requirement Knowledge, Skills & Abilities Excellent technical writing skills Knowledge of engineering first principles Knowledge of parenteral drug product development and manufacturing Able to work in a dynamic environment and adapt to changing priorities Excellence in solving complex engineering and / or scientific problems Expertise with Microsoft Office Familiar with Quality Management Systems Project management skills Attention to detail Oral communication skills Physical Requirements Ability to meet gowning requirements Ability to remain stationary for prolonged periods of time Ability to periodically lift up to 50 lbs. Satisfactory audio-visual acuity
    $73k-94k yearly est. Auto-Apply 60d+ ago
  • Project Manager

    Berkshire Sterile Manufacturing LLC 3.7company rating

    Lee, MA jobs

    The Project Manager is tasked with establishing, maintaining and enhancing the relationship between BSM and external clients. They interact with many different members of the client's team and internal teams to organize and execute plans that ensure mutual profit. Duties and Responsibilities Duties and Responsibilities (cont'd) Manage project initiation and planning Document and manage project scope Define and prioritize project tasks Establish project goals, requirements, and desired results Create, manage, and update project schedules and timeline Define, manage, and update resources Review requirements and specifications for work Participate in identifying and recruiting project personnel Identify and assign duties, responsibilities, and scope of authority to project team personnel Manage project execution Establish schedules and project parameters; develop procedures to accomplish project goals Identify and manage project risk Identify and manage project issues Coordinate the work across multiple projects with other project staff from various functional departments Gather and review status reports prepared by project personnel and modify as necessary Track the execution process to ensure that project team adheres to reporting requirements Facilitate team meetings to discuss and review the work Act as focal point for project problem resolution and escalation Establish conditions for project closure and manage closure Manage project quality delivery Ensure the quality provided and delivered meets that in the agreed plan Ensure that the team follows all formal and informal best practices in project management and other initiatives Report and Communication Prepare project reports for management, clients or others Facilitate interactive sessions Deliver presentations as required Relationship management Establish and maintain customer relationships appropriately Negotiate with clients to reach optimal delivery resolution Manage customer expectations in delivery Manage vendor relations, as appropriate Other duties as assigned Regulatory Responsibilities Exhibit a quality mindset and a willingness to develop Demonstrated knowledge of FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance Supervisory Responsibilities N/A Experience One or more (1+) years previous project management experience preferred Experience in managing multiple projects simultaneously preferred Experience in working with 3rd-party delivery model and structure a plus Experience with process improvement certifications (CMMI) a plus Education Bachelors' Degree or equivalent work experience required PMP Certification a plus Knowledge, Skills & Abilities Knowledge of project management methods and tools (focusing on MS Suite) Strong listening, and oral and written communications skills required Leadership and team building skills a must Problem-solving skills required Coordination skills a must Excellent oral and written communication skills required Self-starter orientation Conflict management experience a plus Ability to deal with change Physical Requirements Ability to sit and/or stand for prolonged periods of time Able to lift up to 10lbs
    $85k-125k yearly est. Auto-Apply 39d ago

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