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Engineering Technical Director- Medical Implants

Boston, MA, USA | Cambridge Consultants

  • Industry:
    Advertising/PR/Marketing/Events
  • Position Type:
    Full-Time
  • Functions:
    General Management
    Engineering
  • Experience:
    12-15 years
Job Description:
58 people have viewed this job

Overview


At Cambridge Consultants we work on medical projects that transform lives. Our clients come to us with challenges that require cutting edge, multidisciplinary solutions. Our patient focused innovation model improves healthcare is partnered with a commitment to fostering the personal growth and development of our team members.


We are looking to further enhance the leadership and vision of our smart implants team.The mission of this team is to drive the technical performance and manage the regulatory landscape of Class III devices. This role will actively engage in all aspects of development from brainstorming ideation to final delivery, helping to create the next generation of game changing implantable and wearable medical devices.


Full Details


Your Role


As part of a multi-disciplinary global smart implants team, you will lead and execute problem solving activities and manage program direction for all stages of the medical product development process. Project work may range from fundamental research to detailed design to advising verification activities. You will deliver implantable and class III design direction and leadership while working collaboratively with our teams to deliver high value impact for our clients.


Some recent inventions we have developed to significantly affect patient lives include:



  • First ever “battery-less” and “lead-less” single chamber pacemaker Link

  • First ever smart orthopedic plate that measures bone healing Link

  • First ever wearable device for treating gait disorders in multiple sclerosis patients Link

  • First ever smart introducer sheath for early detection of bleeding events in patients Link


What a Day Looks Like



  • Take the lead class III role within active implantable device development projects (e.g., neuromodulation implants, stimulation leads and brain interface, implantable sensors, cardiac implants, etc.)

  • Be a thought leader in specifying and pushing the boundaries of tissue and biological interfaces

  • Understand client requirements and drivers, and foresee technical challenges to drive the definition of technical design solutions that meet implantable use cases

  • Scope and guide testing activities related to meeting and informing regulatory requirements


What You Need to Succeed



  • 12+ years’ experience in class II/III medical development, preferably 8+ in class III

  • Strong understanding of design principles as they relate to class III medical products

  • Market specific knowledge related to cGMP or Class II/III regulated products

  • Strong working knowledge of ISO 14971, ISO 13485, IEC60601 series, EN62304, and experience with MDD / MDR regulations.

  • Solid exposure working with Quality Assurance for FDA IDE submission

  • Experience with preclinical and first-in-human studies

  • BS in BioMedical Engineering, BioMechanical Engineering, Mechanical or a related discipline, graduate degree a plus

  • Able to work in a remote model with teams building/testing in our Boston or UK offices


Core Skills and Experience



  • Domain specific knowledge in a relevant area (10993, managing risk, hermetic manufacturing methods, clinical domain, anatomy/physiology, etc.)

  • Relevant class III product experience with knowledge of risk characterization and reliability

  • Experience designing and manufacturing for pre-clinical prototype qualification

  • Breadboard / Benchtop prototype development and integration management

  • Experience working with varying scale of contract manufacturers

  • Solid exposure to designing using risk management procedures (ISO14791)

  • Experience supporting the regulatory submission process as technical lead

  • Clinical familiarity to liaise with KOLs and translate feedback to design team


Even Better:



  • Experience in writing requirements, specifications, test protocols and design documentation

  • Deep domain specific knowledge in a relevant area (materials, tissue, surgical environment, etc.)

  • Knowledge of engineering statistical tools/methods such as DOE, Monte Carlo, Minitab, ANOVA, (DFLS, DFSS, or DRM Green or Black Belt certification a plus).

  • Exposure to the specification of biocompatibility testing methods and test houses

  • Prior consulting experience with exposure to external clients

  • Experience with business development and technical sales

  • Industrial or academic leadership of lab based experimental design and reporting


Affirmative Action/ Veterans/ Disabled


Cambridge Consultants is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Employment Opportunity Posters


If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email us. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail us. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response


Successful applicant must comply with the federal contractor Covid-19 Workplace Safety mandate requirements. 


Benefits



  • Choice of medical dental and vision plans

  • Flexible spending accounts

  • 22 vacation days for full time employees

  • Competitive base salary

  • Pay for performance

  • Profit share bonus plan based on company and individual performance

  • 401K with discretionary company match

  • Life Insurance

  • Relocation assistance, if applicable

  • 13 weeks fully paid Parental Leave

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