Biomedical Engineer Job at Careerscape, Boston, MA

V1Y5Rk5IOGM2bjZVK0g2TmVneHJQM3pOSVE9PQ==
  • Careerscape
  • Boston, MA

Job Description

Our client, a medical device company in Boston, is seeking a Biomedical Engineer to support the design and development of innovative healthcare products. This role involves prototyping, testing, and refining medical devices while ensuring compliance with FDA regulations. The position reports to the Senior Engineering Manager and works closely with R&D, quality, and regulatory teams.

The ideal candidate has experience in medical device development and a strong understanding of design controls and regulatory requirements. This is an on-site position at their Longwood Medical Area facility.

Responsibilities

  • Design and develop medical devices from concept through commercialization
  • Create prototypes and conduct testing to validate design specifications
  • Prepare and maintain design history files and technical documentation
  • Ensure compliance with FDA regulations and ISO 13485 standards
  • Collaborate with cross-functional teams including R&D, quality, and manufacturing
  • Conduct risk analysis and implement design improvements
  • Support clinical evaluations and post-market surveillance activities
  • Stay current with emerging technologies and industry trends

Requirements

  • Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field
  • 3+ years of experience in medical device development
  • Strong understanding of FDA design controls and regulatory submissions
  • Experience with CAD software such as SolidWorks or AutoCAD
  • Knowledge of ISO 13485 and IEC 62304 standards
  • Familiarity with prototyping and testing methodologies
  • Excellent analytical and problem-solving skills
  • Strong written and verbal communication skills

Benefits

  • Competitive base salary with annual bonus potential
  • Medical, dental, and vision insurance
  • 401(k) with company match
  • Paid time off and company holidays
  • Professional development opportunities
  • Life and disability insurance
  • Onsite fitness center
  • Tuition reimbursement program

Job Type: Full-Time | Work Type: On-site | Industry: Biotechnology | Experience: Mid-Senior

Job Tags

Full time,

Similar Jobs

Springboard Healthcare

Travel EP & Cath Lab Technician Job at Springboard Healthcare

 ...Job Description Springboard Healthcare is seeking a travel Cath Lab Technologist for a travel job in Erie, Pennsylvania. Job Description & Requirements ~ Specialty: Cath Lab Technologist ~ Discipline: Allied Health Professional ~ Start Date: ASAP ~ Duration... 

General Dynamics Information Technology

Deputy Program Director- HYBRID (Washington) Job at General Dynamics Information Technology

 ...time off, parental, military, bereavement, jury duty leave, disability and life insurance, and other competitive offerings. We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major... 

Small Potato Trucking

LOCAL CLASS A CDL DRIVER WALMART Job at Small Potato Trucking

 ...opportunities! We like to have the best working environment in the business, so we make the...  ...hiring process! LOCAL JOB DRIVING! WALMART LOADS! Pay starts at $1,200.00 per week...  ...Solo position ~3 months of experience ~ Home DAILY~ Route: NORTH CARLONIA ~... 

West Virginia Property Management

Roofer Job at West Virginia Property Management

 ...Job Description We are actively seeking a skilled and experienced Roofer to join our team. Our companys Roofers repair the customers existing roofing systems and install new roofing systems where required. Additional duties involve clearing hazards from the nearby... 

Revel Staffing

Call Center Manager Job at Revel Staffing

 ...A leading healthcare organization is seeking a compassionate and experienced Call Center Manager to oversee the operation. This position plays a key role in helping individuals and families access life-changing care by ensuring a professional, efficient, and empathetic...