R&D Packaging Engineer - Urgent Need

MillenniumSoft Inc; San Diego (CA); On-site; USD 28,000 - 41,000; Full time

Job summary

MillenniumSoft Inc. in San Diego, CA seeks a mid-level R&D Packaging Engineer on a 12-month contract to drive packaging design and development for infusion-related devices. This role focuses on development, qualification, and launch phases with emphasis on design control practices and DFSS methodologies.

The engineer will lead experiments, develop test methods, and support global regulatory filings, working both in-lab and on-site with cross-functional teams.

Qualifications

• BS in Mechanical, Materials or Biomedical Eng.
• 5 years experience or 3 years with advanced degree in relevant field and ISO 11607/ASTM packaging
• SolidWorks or equivalent CAD tool

Responsibilities

• Lead R&D deliverables through medical device packaging design control processes.
• Collaborate in cross-functional teams to develop IPD products with rigorous engineering practices.
• Engineer robust products applying DFSS principles and Six Sigma tools (Kaizen).
• Transfer designs to Manufacturing and support regulatory filing strategies.

Skills

SolidWorks CAD

Education

BS in Mechanical/ Materials/ Biomedical Eng

Job description

Level of Experience : Mid-Level

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

Education : BS - Mechanical Engineering, Materials Engineering or Biomedical Engineering

Work experience : 5 years or 3 years plus an advanced degree in Mechanical, Packaging or Biomedical Engineering

Position : R&D Packaging Engineer

Location : San Diego, CA

Duration : 12 Months

Total Hours/week : 40.00

pay rate-$20-30/hr

1st Shift

Client : Medical Devices Company

Job Summary

• The R&D Packaging Engineer III will impact health care and the MDS business groups by driving commercialization of new products and design changes for current products through development, qualification and launch phases.
• The R&D Packaging Engineer III is energetic and excited to bring innovation to commercialization.
• He or she will use their deep technical expertise to develop novel medical devices, including concept development, device verification and validation, and root cause analysis.
• As challenges arise, she or he will not only carry out experiments to resolve it, but also recommend the path forward.

Job Description

• Research and Development Packaging 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 packaging technical strategies.
• Demonstrates working knowledge of Engineering principles and its application in solving standard technical problems.
• Demonstrates working knowledge of packaging product design, development, and design control process.
• Develops technical plans for packaging requirements, and specifications, conducts analytical and empirical feasibility studies, develops test methods to verify and validate in order to transfer designs alongside Manufacturing. Demonstrates knowledge to provide packaging 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, and implement IPD products through the application of rigorous engineering practices
• Engineer robust products through strong understanding and application of engineering fundamentals and DFSS principles and/or Six Sigma tools (Kaizen, process improvement).
• 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 on development of ISO 11607, ASTM Packaging Standards and Medical Device Packaging Design
• SolidWorks or equivalent CAD tool
• Critical thinking - able to work with moderate guidance in own area of knowledge.
• 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.