Current jobs related to Medical Device Verification - Woburn - Cytrellis Biosystems

  • Manufacturing Engineer- Medical Device

    1 day ago

    Woburn, MA, United States Michael Page Full time

    Join a multidisciplinary team focused on designing and validating medical devices, encompassing line extensions, product enhancements, and technology transfers. This role requires independent handling of complex tasks such as prototyping, testing, data analysis, report writing, and project management.Client DetailsThis client is known for its dedication to...

  • Lead Quality Assurance Engineer

    3 weeks ago

    Woburn, Massachusetts, United States BD Full time

    Job OverviewThis role will act as the Quality Assurance lead for the manufacturing operations. The main focus will be on addressing production, quality control, and laboratory-related challenges by implementing robust solutions, updating facility documentation for precision and adherence, validating equipment/processes/products as necessary, and...

  • Immunoassay Process Engineer

    3 weeks ago

    Woburn, Massachusetts, United States Spear Bio Full time

    Spear Bio is an innovative and rapidly expanding start-up focused on revolutionizing the field of diagnostics through our cutting-edge immunoassay platform. We are headquartered in Woburn, Massachusetts, and are dedicated to delivering high-quality solutions that utilize minimal sample volumes while ensuring exceptional data integrity.We are currently...

  • Surgical Technology Consultant

    3 weeks ago

    Woburn, Massachusetts, United States ForTec Medical Full time

    At ForTec Medical, we provide a dynamic work environment, comprehensive training on cutting-edge medical technologies, and opportunities for collaboration with healthcare professionals.Our employees enjoy a robust benefits package that includes:• Competitive salary with overtime pay for hours exceeding 40 per week• 7 Company Paid Holidays plus 1 Floating...

  • Travel Nuclear Medicine Technologist

    2 weeks ago

    Woburn, Massachusetts, United States Alliance Medical Staffing Full time

    Job DetailsWe are seeking a skilled Nuclear Medicine Technologist to join our team at Alliance Medical Staffing.Job ResponsibilitiesPerform diagnostic imaging procedures using nuclear medicine equipment.Administer radiopharmaceuticals and operate imaging devices to produce high-quality images.Collaborate with healthcare professionals to ensure accurate...

  • Clinical Technology Specialist

    4 months ago

    Woburn, United States ForTec Medical Full time

    Job DescriptionJob DescriptionCompany DescriptionAt ForTec, we offer an independent work environment, training on the top medical technologies, and interaction with physicians and medical professionals. We provide our employees with a generous benefits package including: Competitive salary - PLUS time and a half paid for hours worked over 40 per week7...

  • Clinical Technology Specialist

    2 months ago

    Woburn, United States ForTec Medical Full time

    Job DescriptionJob DescriptionCompany DescriptionAt ForTec, we offer an independent work environment, training on the top medical technologies, and interaction with physicians and medical professionals. We provide our employees with a generous benefits package including: Competitive salary - PLUS time and a half paid for hours worked over 40 per week7...

  • Process Development Engineer or Scientist

    3 weeks ago

    Woburn, United States Spear Bio Inc. Full time

    Process Development Engineer or Scientist Location: Woburn, Massachusetts Department: Product Development Employment Type: Full Time – Onsite Minimum Experience: Experienced Spear Bio is a well-funded and rapidly growing start-up company based in Woburn, Massachusetts. We are focused on bringing to market a novel ultrasensitive immunoassay platform capable...

  • Assembly Technician

    1 week ago

    Woburn, Massachusetts, United States Adecco Full time

    Job OverviewAdecco is seeking a skilled Assembler to work in the greater Bedford, MA area. The ideal candidate will have previous experience in medical device manufacturing and a strong work ethic.Key Responsibilities:Perform general assembly on medical devicesFollow standard operating procedures for assembly specificationsEnsure attention to detail and...

  • Assembly Specialist

    1 week ago

    Woburn, Massachusetts, United States Adecco Full time

    Job SummaryAdecco is seeking a skilled Assembly Specialist to join our team in the medical device manufacturing industry. The ideal candidate will have previous experience in assembly and a strong work ethic.Key Responsibilities:Perform general assembly on medical devicesFollow standard operating procedures for assembly specificationsEnsure attention to...

  • Biomedical Technician Specialist

    6 days ago

    Woburn, Massachusetts, United States symplr Recruiting Sales Full time

    Job Title: Biomedical TechnicianJob Summary:We are seeking a highly skilled Biomedical Technician to join our team at symplr Recruiting Sales. As a Biomedical Technician, you will be responsible for ensuring the proper functioning of medical equipment and devices, performing routine maintenance and repairs, and troubleshooting complex technical issues.Key...

  • SAP Supply Chain and Logistics Expert

    4 days ago

    Woburn, Massachusetts, United States Sirtex Medical Full time

    About the RoleWe are seeking a highly skilled SAP Supply Chain and Logistics Business Analyst to join our team at Sirtex Medical. As a key member of our organization, you will be responsible for analyzing business requirements and translating them into technical specifications.Key ResponsibilitiesDesign and customize SAP modules related to Supply Chain and...

  • Senior Legal Counsel and Compliance Officer

    2 weeks ago

    Woburn, Massachusetts, United States Sirtex Medical Inc. Full time

    Job DescriptionSirtex Medical Inc. is a leading global healthcare company seeking a highly skilled Senior Legal Counsel and Compliance Officer to lead our compliance function in the Americas. This role will drive healthcare compliance, employment, and related compliance activities, while providing legal support across the organization.Key...

  • Legal Counsel

    2 weeks ago

    Woburn, Massachusetts, United States Sirtex Medical Full time

    Job DescriptionThe Legal Counsel & Compliance Officer will lead the compliance function in the Americas, driving healthcare compliance as well as employment and related compliance activities. This role will provide legal support across the Sirtex business globally.Key ResponsibilitiesCompliance Leadership: Lead the compliance function in the Americas,...

  • Senior Manufacturing Engineer

    2 weeks ago

    Woburn, Massachusetts, United States RCM Technologies Full time

    Job Title: Senior Manufacturing Engineer - Process OptimizationJob Function: The Manufacturing Engineer will drive Engineering requirements within our medical device client's Operations team and play an active part in cross-functional support, including Quality, R&D, and Regulatory Affairs.Key Responsibilities:Develop and execute required validations in line...

  • Senior Manufacturing Engineer

    2 months ago

    Woburn, United States RCM Technologies Full time

    Job Title: Senior Manufacturing EngineerJob Function: The Manufacturing Engineer will drive Engineering requirements within our medical device client's Operations team and play an active part in cross functional support, including Quality, R&D and Regulatory Affairs. Lead the ME team in the company's relocation of the manufacturing line.Job Type: Long Term...

  • Compliance Analyst

    2 months ago

    Woburn, United States Biofrontera Full time

    Job DescriptionJob DescriptionJob Purpose/SummaryThe Compliance Analyst is responsible for reviewing and analyzing data necessary for internal operations and external reporting and executing the processes to detect and identify activities which may be non-compliant with the applicable laws, industry requirements and company policies governing pharmaceutical...

  • Regulatory Compliance Specialist

    3 weeks ago

    Woburn, Massachusetts, United States Biofrontera Full time

    Job OverviewPosition SummaryThe Regulatory Compliance Specialist plays a crucial role in evaluating and interpreting data essential for both internal processes and external disclosures. This position is tasked with implementing measures to uncover and address any activities that may not align with relevant laws, industry standards, and internal policies...

  • Legal Counsel

    2 weeks ago

    Woburn, United States Sirtex Medical Inc. Full time

    Legal Counsel & Compliance Officer - AmericasFull-timeSirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative...

  • Legal Counsel

    2 weeks ago

    Woburn, United States Sirtex Medical Inc. Full time

    Legal Counsel & Compliance Officer - AmericasFull-timeSirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative...

Medical Device Verification

4 months ago

Woburn, United States Cytrellis Biosystems Full time
Job DescriptionJob DescriptionSalary:

➡️ We're HIRING Medical Device Verification & Validation Engineer

We’re looking for passionate and ambitious individuals to join the Cytrellis Team

 

What makes Cytrellis different:

✔️ Unique product offering – ellacor by Cytrellis is the FIRST and ONLY FDA-cleared device for non-surgical, scarless skin removal. 

✔️ Untapped Market Potential: 5x account growth in the last 8 months

✔️Voted Best Non-Surgical Skin Removal Procedure

✔️ Developed by aesthetic industry innovators Rox Anderson, MD and Jay Austen, MD from Mass General Hospital / Harvard Medical School


Don't miss your chance to join an amazing team that is shaping the future of aesthetics. 


Summary

As a member of the Product Development team, the Medical Device Verification & Validation Engineer will be responsible for designing, executing, and analyzing tests on electro-mechanical based medical devices to ensure their quality, safety, and compliance with regulatory standards.

 

The ideal candidate should have a strong background in medical device testing, knowledge of electro-mechanical designs, relevant regulations and standards. They will have excellent analytical and problem-solving abilities. The Medical Device Verification & Validation Engineer will work closely with the R&D and Quality teams to ensure that the company’s products and systems meet all design requirements, and that activities are conducted in compliance with company policies as well as appropriate regulations for medical devices. The position may be required to perform all, or a combination of the following essential responsibilities as determined by necessity.

 

This role is located at the Company’s Headquarters located in Woburn, MA.

 

Essential Duties and Responsibilities

  • Develop test plans and strategies based on regulatory requirements, industry standards, and product specifications. 
  • Design and execute test protocols to evaluate the performance, functionality, and safety of medical devices. 
  • Utilize specialized equipment and simulate real-world conditions to conduct tests. 
  • Analyze test data, interpret results, and collaborate with cross-functional teams to troubleshoot issues and optimize device performance. 
  • Generate comprehensive test reports documenting test procedures, results, and any non-compliance issues. 
  • Ensure compliance with relevant regulations, such as FDA guidelines or international standards like ISO 13485. 
  • Collaborate with product designers, quality assurance personnel, and regulatory affairs specialists to ensure effective testing processes. 
  • Participate in design reviews, providing input on testability and manufacturability of medical devices. 
  • Contribute to risk assessment activities and ensure that devices meet design requirements and user needs through verification and validation tests. 
  • Identify opportunities to streamline testing procedures, enhance efficiency, and optimize resource utilization. 
  • Participates in the design and development of automated tools, test fixtures, and unit tests.
  • Stay updated on emerging technologies, industry trends, and regulatory changes relevant to medical device testing.
  • Performs other duties as required.

 

Education and/or Experience

  • Bachelor’s degree in Biomedical Engineering, Electrical Engineering, or a related field.  
  • 5 years of experience in medical device testing or a similar role. 
  • Strong knowledge of medical device regulations and standards (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls, FDA SW Guidelines). 
  • Proficient in designing and executing test plans, protocols, and procedures. 
  • Experience with specialized testing equipment and tools (Git, SVN, WinSCP, TeraTerm, VMWare, VirtualBox). 
  • Experience working with test case/work management tools such as Helix and Jira. 
  • Experience working with different test methodologies (white-box testing, black-box testing, boundary value analysis, equivalence partitioning, use case testing). 
  • Experience working with embedded software, Linux and Android OS platforms. 
  • Experience programming and reviewing code (C++, XML, Java, Python). 
  • Ability to analyze and interpret complex test data. 
  • Strong written and verbal communication skills. 
  • Detail-oriented with a high level of accuracy. 
  • Ability to work effectively in cross-functional teams. 
  • Familiarity with risk assessment methodologies and verification/validation processes. 

 

 

Physical Requirements

  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift up to 15 pounds on occasion.
  • Must be able to access and navigate each department at the organization’s facility.
  • This position requires minimal travel; average travel for this position is less than 5% with some variation based upon the demands of the business imperatives.