Principal RD Engineer

Gateway Recruiting; Saint Paul (MN); On-site; USD 100,000 - 130,000; Full time

Job summary

Gateway Recruiting is seeking a Principal Engineer in Saint Paul, Minnesota, responsible for providing engineering support in the development of innovative medical devices. This role requires multidisciplinary engineering knowledge and hands-on experience in R&D and testing of medical devices, along with a focus on compliance with FDA regulations.

The ideal candidate should have a Bachelor’s degree in Mechanical Engineering, at least 10 years of relevant experience, and skills in project management and manufacturing processes.

Qualifications

• Minimum 10 years of R&D engineering experience.
• Experience in designing and testing medical devices required.
• Ability to manage and lead projects effectively.

Responsibilities

• Conduct empirical and experimental analysis.
• Develop prototypes and design innovative devices.
• Collaborate with consultants and the medical community.

Skills

R&D engineering experience

Designing medical devices

Project management skills

Plastics injection molding

ProE and Solidworks CAD experience

Familiarity with manufacturing processes

Education

Bachelor's Degree in Mechanical Engineering

Master's Degree or equivalent

Job description

JOB SUMMARY:

The Principal Engineer is responsible for providing engineering support in the creation and the development of new division products.

This role will use multidisciplinary engineering knowledge to design and develop innovative medical devices or components/subsystems in support of company's strategic plan.

MAIN RESPONSIBILITIES:

• Run empirical and experimental analysis.
• Conceptualize new devices using material knowledge and innovative mechanical design.
• Conceive and build prototypes.
• Work with outside consultants, vendors, and the medical community.
• Project planning: Plan, coordinate, and execute activity in support of project goals.
• Identify and mitigate project risks.
• Support animal and bench testing and clinical evaluations.
• Support design reviews and physician visits.
• Establish requirements and specifications
• Test method and model development
• Maintain knowledge of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.).
• Ensure compliance with procedural and documentation requirements of SJM, FDA and ISO design controls
• Technologies: Biocompatible material selection for delivery systems and implants, bioprosthetic implants, mechanical design of biocompatible metals and plastics.
• Machining: Molding, Extrusion, Thermoforming, and Packaging and Sterilization
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

QUALIFICATIONS:

Education:

• Major/Field of Study or Equivalent Bachelors Degree Mechanical Engineering or related
• An equivalent combination of education and work experience Masters Degree
• Mechanical Engineering preferred experience/background experience

Experience Details:

• Minimum 10 years of experience primarily in R&D engineering.
• Designing and testing medical devices is required, preferably interventional cardiology devices.
• Experience with a variety of manufacturing processes and designing for manufacturability is required.
• Project leadership and management skills required.
• Plastics injection molding and/or extrusion experience required.
• Metals experience a plus – stainless steel and nitinol wires – including bonding methods CAD Experience in ProE and/or Solidworks a plus.
• Open to or experienced in the latest design tools and techniques (i.e., Six Sigma, Design for Manufacturability, Analytical Design)
• Ability to travel, including internationally.