Demo

Mechanical & Biomedical Engineer

Katalyst HealthCares and Life Sciences
Belleville, NJ Full Time
POSTED ON 4/22/2025
AVAILABLE BEFORE 5/18/2025

Responsibilities :

  • Lead / contribute to device development, design controls and risk management strategy for the assigned projects.
  • Lead the implementation and / or ensure effective execution of the device development strategy, design controls and risk management activities for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers.
  • Proactively resolve project obstacles and challenges and communicate device development strategy, design controls and risk management approaches within Device Development and with external suppliers.
  • Understand and apply regulatory / compliance requirements related to design controls and risk management activities.
  • Proven ability to work with team members of diverse skill sets and backgrounds.
  • Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership.
  • Excellent communication, presentation, negotiation, project management, and organizational skills.

Requirements :

  • B.A. / B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 5 years of related experience.
  • Previous experience in inhalation drug delivery.
  • Has broad knowledge of medical device development, design controls and risk management.
  • Led and managed development of DHF (design history file) deliverables for medical devices.
  • Knowledge of U.S. and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93 / 42 / EEC, etc.
  • Self-motivated and work independently.
  • Experience with the inhalation products (such as Dry-power inhaler), combination products or a medical device component of a combination product.
  • Master's degree in one of the above disciplines plus 3 years related experience.
  • Experience with device design, requirement management, FMEA, design verification, design validation, statistical sampling, and control strategy has context menu.
  • If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
    Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

    What is the career path for a Mechanical & Biomedical Engineer?

    Sign up to receive alerts about other jobs on the Mechanical & Biomedical Engineer career path by checking the boxes next to the positions that interest you.
    Income Estimation: 
    $65,088 - $83,360
    Income Estimation: 
    $83,633 - $115,564
    Income Estimation: 
    $160,327 - $202,757
    Income Estimation: 
    $194,528 - $245,889
    Income Estimation: 
    $77,468 - $96,380
    Income Estimation: 
    $88,978 - $112,048
    Income Estimation: 
    $88,978 - $112,048
    Income Estimation: 
    $110,667 - $136,248
    Income Estimation: 
    $110,667 - $136,248
    Income Estimation: 
    $138,844 - $172,920
    View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

    Job openings at Katalyst HealthCares and Life Sciences

    Katalyst HealthCares and Life Sciences
    Hired Organization Address Putnam, CT Full Time
    Responsibilities : Provide quality assurance services to ensure the integrity of products received and shipped out, serv...
    Katalyst HealthCares and Life Sciences
    Hired Organization Address Chelmsford, MA Full Time
    Responsibilities : Create Electrical Block diagrams (AutoCAD). Create Bills of Materials. Create Digital I / O Maps. Cre...
    Katalyst HealthCares and Life Sciences
    Hired Organization Address Waltham, MA Full Time
    Responsibilities : ssists in optimization of current processes, and development of new processes in support of R&D, Manu...
    Katalyst HealthCares and Life Sciences
    Hired Organization Address Richmond, VA Full Time
    Responsibilities : Develop and implement comprehensive validation plans for packaging lines, labelers, case packers, and...

    Not the job you're looking for? Here are some other Mechanical & Biomedical Engineer jobs in the Belleville, NJ area that may be a better fit.

    Mechanical Engineer

    ACS - Engineer. Integrate. Build., Newark, NJ

    Mechanical Engineer

    ACS - Engineer. Integrate. Build., Jersey, NJ

    AI Assistant is available now!

    Feel free to start your new journey!