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Product Analysis Engineer I - Post Market Role (Electronics Lab)

TekOne IT Services Pvt. Ltd.
Burlington, MA Contractor
POSTED ON 1/16/2025 CLOSED ON 3/12/2025

What are the responsibilities and job description for the Product Analysis Engineer I - Post Market Role (Electronics Lab) position at TekOne IT Services Pvt. Ltd.?

Job Title: Product Analysis Engineer I (Electronics Lab)

Location: Burlington, MA

Duration: 6 Months (100% Onsite)

Position Type: Entry-Level Post Market Role

Additional Information

  • Local candidates only.
  • Potential for extension or conversion based on performance and budget.

Job Summary

  • This position will support failure analysis on biomedical implant products in an electronics lab environment.
  • The role involves conducting root cause investigations, analyzing failures, and collaborating with cross-functional teams to identify and implement quality improvements.

Key Responsibilities

  • Perform failure analysis on explanted biomedical implant products.
  • Apply theoretical principles and creative techniques to identify root cause failure mechanisms.
  • Conduct circuit analysis and component-level failure analysis.
  • Develop and implement investigative protocols and reports.
  • Support product quality initiatives in alignment with Quality Management Systems (QMS) and regulatory requirements.
  • Collaborate with Product Development, Engineering, Manufacturing, and Product Surveillance teams.
  • Mentor and provide guidance to less experienced lab staff.
  • Ensure compliance with FDA regulations and other regulatory requirements.
  • Maintain positive and cooperative communication with all stakeholders.

Qualifications

  • Bachelor’s degree in Engineering (Electrical or Biomedical preferred).
  • Up to 2 years of engineering work experience, with a preference for those with co-op or internship experience.
  • Knowledge of global regulations for medical device reporting and medical terminology is a plus.
  • Strong verbal and technical writing skills.
  • Ability to multitask, prioritize, and work independently or in a team environment.
  • Effective time management and organizational skills.

Working Conditions

  • Combination of office and lab work (1/3 desk work, 2/3 lab work).
  • Requires PPE/gowning, including head and beard covers, shoe covers, gloves, mask, etc.
  • Must be comfortable working with deadlines and cross-functional teams.

Interview Process

  • Initial phone screen followed by 1-2 onsite interviews.

Ideal Candidate Profile

  • Bachelor’s in Engineering with 1-2 years of relevant experience or recent co-op/internship experience.
  • Strong analytical skills and attention to detail, with the ability to work effectively under pressure and meet deadlines.
  • A Master's degree is acceptable; however, PhDs are not preferred.
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