Product Development Engineer - Urgent Need

MillenniumSoft Inc; San Diego (CA); On-site; USD 71,635,000 - 85,962,000; Full time

Job summary

MillenniumSoft Inc is seeking a Product Development Engineer in San Diego, CA, for a 12-month contract in engineering/technical roles. The role emphasizes leading R&D deliverables, cross-functional collaboration, and robust design control processes for infusion preparation and delivery devices.

The candidate will develop tests, write protocols, and support regulatory filings while working in a hybrid environment with 40 hours per week. Lab and office presence 80%+ in San Diego or Brea, CA.

Qualifications

• BS degree in Mechanical, Materials, or Biomedical Engineering or equivalent.
• Experience with medical device design control processes and documentation.
• Proven ability to manage multiple projects in parallel.
• SolidWorks or equivalent CAD tool proficiency.
• Ability to work in cross-functional teams with marketing, regulatory, and manufacturing.

Responsibilities

• Lead R&D deliverables through the medical device design control process for infusion sets and related devices.
• Collaborate across functions to plan, develop, modify, implement, and support IPD products with rigorous engineering practices.
• Engineer products using solid DFSS principles and DFMEA where applicable.
• Develop design inputs, run feasibility studies, and guide design verification and validation activities.
• Provide design documentation to support regulatory filings and manufacturing transfer.

Skills

SolidWorks

Project management

Cross-functional teamwork

Design control

Analytical thinking

Education

BS in Mechanical/Materials/Biomedical Engineering

Job description

Job Category : Engineering/Technical

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

• Research and Development Engineering is responsible for development and lifecycle management of products through medical device design control processes and good engineering and documentation practices. The Infusion Preparation and Delivery (IPD) platform seeks a hardworking and passionate leader to develop and drive technical strategies.
• Demonstrates working knowledge of Engineering principles and its application in solving standard technical problems.
• Demonstrates working knowledge of product design, development, and design control process.
• Develops technical plans for design inputs and outputs, conducts analytical and empirical feasibility studies, develops test methods to verify and validate subsystems and systems in order to transfer designs alongside Manufacturing.
• Demonstrates knowledge to provide design documentation to support global Regulatory filing strategies. Applies basic statistical techniques and utilizes design of experiments with moderate guidance.
• Collaborates within a cross-functional team to plan, develop, modify, implement, and support IPD products through the application of rigorous engineering practices. Works with moderate guidance to achieve project objectives.
• Flexible work arrangements allow our team members to collaborate remotely and onsite to experiment, discover, create, and simply connect with others toward a common purpose.
• R&D engineers are responsible for leading and supporting projects as part of a cross-functional global team.
• This is a highly collaborative position and requires excellent leadership, verbal, and written communication skills.
• Projects will involve requirements definition, developing test methods, writing test protocols, reports, executing verification testing, solving test or design issues and other types of mechanical engineering activities.
• Position will be required to be in the lab and office more than 80% of the time in San Diego or Brea, CA.

Position : Product Development Engineer

Location : San Diego, CA

Duration : 12 Months

Total Hours/week : 40.00

pay range -$25-30/hr

1st Shift

Client : Medical Devices Company

Job Category : Engineering/Technical

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Job Description

• Research and Development Engineering is responsible for development and lifecycle management of products through medical device design control processes and good engineering and documentation practices. The Infusion Preparation and Delivery (IPD) platform seeks a hardworking and passionate leader to develop and drive technical strategies.
• Demonstrates working knowledge of Engineering principles and its application in solving standard technical problems.
• Demonstrates working knowledge of product design, development, and design control process.
• Develops technical plans for design inputs and outputs, conducts analytical and empirical feasibility studies, develops test methods to verify and validate subsystems and systems in order to transfer designs alongside Manufacturing.
• Demonstrates knowledge to provide design documentation to support global Regulatory filing strategies. Applies basic statistical techniques and utilizes design of experiments with moderate guidance.
• Collaborates within a cross-functional team to plan, develop, modify, implement, and support IPD products through the application of rigorous engineering practices. Works with moderate guidance to achieve project objectives.
• Flexible work arrangements allow our team members to collaborate remotely and onsite to experiment, discover, create, and simply connect with others toward a common purpose.
• R&D engineers are responsible for leading and supporting projects as part of a cross-functional global team.
• This is a highly collaborative position and requires excellent leadership, verbal, and written communication skills.
• Projects will involve requirements definition, developing test methods, writing test protocols, reports, executing verification testing, solving test or design issues and other types of mechanical engineering activities.
• Position will be required to be in the lab and office more than 80% of the time in San Diego or Brea, CA.

Job Responsibilities

• Lead R&D deliverables throughout the medical device design control process for intravenous infusion sets and connection devices
• Collaborate within a cross-functional team to plan, develop, modify, implement, and support IPD products through the application of rigorous engineering practices
• Engineer robust products through strong understanding and application of engineering fundamentals and DFSS principles.
• Develop technical plans and guide the team to develop design inputs, conduct analytical and empirical feasibility studies, refine product configurations and designs, verify and validate subsystems and systems, concurrently transfer designs alongside Manufacturing and Operations, and provide design documentation to support global Regulatory filing strategies
• Execute design verification testing to confirm design outputs meet design input requirements.

Required Qualifications

• BS - Mechanical Engineering, Materials Engineering or Biomedical Engineering
• Work experience 5 years or 3 years plus an advanced degree
• Critical thinking - able to work with moderate guidance in own area of knowledge.
• SolidWorks or equivalent CAD tool
• Ability to manage multiple projects of varying scopes in parallel
• Ability to work leading or as part of a cross-functional team with members from marketing, sales, clinical, regulatory, medical affairs, quality, manufacturing, etc.
• Experience with medical device design control processes and creating and maintaining design control documentation.