Design Project Engineer - Onsite - Kenosha, WI

Exalta Group

$70K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • BS in engineering, preferably in mechanical or biomedical fields, or equivalent experience.
  • 1 year of product development experience in the medical device sector.
  • Proficient in creating 3D part files and 2D technical drawings using SolidWorks.
  • Knowledge of regulatory and quality requirements in the medical device industry.
  • Experience in analyzing test data and generating reports.

Responsibilities

  • Research and develop surgical implants and instruments to meet regulatory and quality standards.
  • Create 3D models and 2D drawings using SolidWorks.
  • Analyze test data and generate validation reports for design specifications.
  • Collaborate with cross-functional teams to establish project plans and requirements.
  • Assist Manufacturing, Supply Chain, Quality, and Regulatory departments as necessary.
  • Interface with suppliers to support the manufacturing process.
  • Observe surgical procedures in an operating room or cadaver lab.

Benefits

  • Opportunity to work onsite in a collaborative team environment.
  • Exposure to real-world surgical procedures and practices.
  • Engagement with cross-functional teams, enhancing professional growth.
  • Chance to influence product development in a cutting-edge industry.
Full Job Description
*ONSITE POSITION BASED IN KENOSHA, WISCONSIN*

Description: Develop new medical devices and/or make enhancements to existing products through regular interaction with a cross-functional team. The Design Engineer must also assist with relevant development processes and conform to the guidelines described in the company's quality system and other policies.

Primary Job Responsibilities:
• Research and develop surgical implants and instruments in accordance with regulatory and quality requirements.
• Create 3D part files and 2D technical drawings using SolidWorks.
• Analyze test data and generate reports to verify or validate that designs meet functional and performance specifications.
• Interact and coordinate with other departments to establish project plans, product requirements, and other documentation activities in accordance with design control and risk management procedures.
• Provide assistance to the Manufacturing, Supply Chain, Quality and Regulatory departments as needed.
• Interface with suppliers and provide support during the manufacturing process.
• Follow organizational and group guidelines, procedures, protocols.
• View surgical procedures in operating room or cadaver lab.

Secondary Job Responsibilities:
• Inspect inventory components and supervise first product builds
• Support business development and management activities
• Participate in research assignments including trade show and other conference attendance
• Respond to field questions related to products and projects when necessary

Educational Requirements: BS in engineering (mechanical and/or biomedical a plus) or equivalent work experience.

Experience Requirements: 1-year product development experience in medical device desired.

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