Senior R&D Engineer

Infosoft Inc.; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Infosoft Inc. is seeking a Senior R&D Engineer to contribute to product engineering and design maintenance within a regulated medical device manufacturing environment.

You will evaluate engineering changes, review drawings and documentation, and support verification and validation activities as needed. The role requires hands-on R&D experience with medical devices or a similarly regulated industry and strong collaboration with cross-functional teams to address technical issues and drive product

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering or related field.
• 5+ years of relevant experience with a bachelor's degree, or 2+ years with master's or PhD.
• Hands-on R&D experience reviewing engineering drawings, specifications, and documentation.
• Understanding of design change processes, engineering change control, and documentation management.
• Ability to prepare clear technical reports and maintain accurate engineering records.
• Experience in a regulated industry such as medical devices, pharmaceuticals, aerospace, or similarly controlled manufacturing.
• Ability to work collaboratively with cross-functional engineering and quality teams.
• Preferred: Experience with SolidWorks or comparable CAD software.
• Preferred: Exposure to verification and validation protocols, product complaint investigations, and root-cause analysis.
• Preferred: Familiarity with quality systems and regulatory documentation.

Responsibilities

• Review engineering drawings, product specifications, and technical records for accuracy and completeness.
• Support product design modifications and coordinate the associated engineering change-control activities.
• Update design documentation and ensure revisions are properly recorded and maintained.
• Draft, organize, and review technical reports, engineering assessments, and supporting documentation.
• Assist with the evaluation of product performance issues and contribute to technical problem-solving.
• Participate in product complaint reviews and help investigate potential technical causes.
• Support verification and validation activities by following established protocols and documenting results.
• Work with engineering and quality personnel to address documentation gaps and engineering concerns.
• Coordinate with manufacturing and other stakeholders to communicate design updates and resolve implementation questions.
• Review engineering records for alignment with applicable quality procedures and regulatory expectations.
• Help maintain consistency across design records, drawings, specifications, and related technical files.
• Contribute to engineering reviews and provide technical input to support product changes and ongoing product improvement.

Skills

R&D experience

Cross-functional collaboration

Technical reporting

Education

Bachelor's degree in Mechanical Engineering or Biomedical Engineering

Tools

SolidWorks

Job description

Our Client is a Global medical device Manufacturer.

Our client is seeking a Senior R&D Engineer to contribute to product engineering and design maintenance activities within a regulated manufacturing environment. This position will focus on evaluating engineering changes, reviewing technical drawings, maintaining controlled documentation, and preparing engineering reports. The engineer will work closely with cross-functional teams to address product-related technical issues and support design verification activities as needed. Candidates with hands-on R&D or product engineering experience in medical devices or another regulated industry are encouraged to apply.

• Review engineering drawings, product specifications, and technical records for accuracy and completeness.
• Support product design modifications and coordinate the associated engineering change-control activities.
• Update design documentation and ensure revisions are properly recorded and maintained.
• Draft, organize, and review technical reports, engineering assessments, and supporting documentation.
• Assist with the evaluation of product performance issues and contribute to technical problem-solving.
• Participate in product complaint reviews and help investigate potential technical causes.
• Support verification and validation activities by following established protocols and documenting results, as required.
• Work with engineering and quality personnel to address documentation gaps and engineering concerns.
• Coordinate with manufacturing and other stakeholders to communicate design updates and resolve implementation questions.
• Review engineering records for alignment with applicable quality procedures and regulatory expectations.
• Help maintain consistency across design records, drawings, specifications, and related technical files.
• Contribute to engineering reviews and provide technical input to support product changes and ongoing product improvement.

Requirements:

• Bachelor's degree in Engineering, preferably Mechanical Engineering or Biomedical Engineering.
• Minimum relevant experience of 5 years with a bachelor's degree, or 2 years with a master's degree or PhD.
• R&D experience
• Practical experience reviewing engineering drawings, specifications, and technical documentation.
• Understanding design change processes, engineering change control, and documentation management.
• Ability to prepare clear technical reports and maintain accurate engineering records.
• Experience in a regulated industry, such as medical devices, pharmaceuticals, aerospace, or similarly controlled manufacturing.
• Ability to work collaboratively with cross-functional engineering and quality teams.
• Preferred: Experience with SolidWorks or comparable CAD software.
• Preferred: Exposure to verification and validation protocols, product complaint investigations, and technical root-cause analysis.
• Preferred: Familiarity with quality systems and regulatory documentation.