Engineer - Hybrid

Ultimate Staffing; Tempe (AZ); Hybrid; USD 85,000 - 120,000; Full time

Job summary

Ultimate Staffing is seeking an engineer to design, validate and bring medical device products to market. Responsibilities include translating user needs into design inputs, performing feasibility tests, and developing detailed engineering drawings with CAD/CAE tools.

The role requires independent work, collaboration with cross‑functional teams, and adherence to design controls and regulatory requirements. The ideal candidate holds a university degree and has experience in regulated

Qualifications

• Degree in engineering or related field required or equivalent experience.
• Experience designing and validating medical device components.
• Knowledge of design controls and regulatory expectations.
• Ability to communicate technical information to teams.

Responsibilities

• Research, design, develop and verify components and systems for medical devices.
• Translate user needs into design inputs and system-level designs.
• Develop bench testing methods and DOE for verification activities.
• Collaborate across R&D, Quality, Manufacturing and Regulatory teams.

Skills

Communication

Test fixtures

Verification & Validation

Regulated env knowledge

Education

University degree

Tools

CAD

CAE

Job description

Shift Details: This role will be Mon-Fri 8:00am - 5:00pm. It will be hybrid with the expectation of at least three days on site in Tempe.

Job Description:

Designs, validates and brings new products to market. Specifies precise new product functional requirements; designs, tests and integrates components to produce final designs; and evaluates the design's overall effectiveness, cost, reliability and safety. Designs, develops, executes and evaluates fitness-for-use testing, product specifications and process validation plans; creates and reviews material part specifications and bills of materials. Collaborates with internal manufacturing partners, contract manufacturers, designers and product specialists to optimize designs for manufacturability. Utilizes CAD (Computer Aided Design) or CAE (Computer Aided Engineering) systems to model new designs and produce detailed engineering drawings.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent.

KEY AREAS OF RESPONSIBILITY: What you will do:

Technical Responsibilities:

• Research, design, develop, modify, and verify components and systems for medical devices with minimal supervision.
• Translate user needs to design inputs/ specifications and produce system-level designs.
• Develop and analyze solutions, prototyping one or more options to provide proof of concept.
• Apply fundamental and some advanced concepts, practices and procedures for problem solving.
• Support problem solving, root cause analysis, identify potential solutions, and evaluate them against requirements.
• Develop bench testing methods, conduct measurement system analysis, and develop DOE.
• Conduct research and studies to support product design.

Business Responsibilities:

• Demonstrate advanced understanding of customer needs and design inputs.
• Demonstrate proficiency with product's intended use and clinical procedures.
• Learn how the financial models are constructed
• Support Voice of Customer sessions internally and with clinicians to develop an understanding of customer needs
• Apply understanding of customer needs to development of robust and appropriate design inputs.
• Understand the product's intended use and clinical procedures.
• Apply understanding of the impact of design decisions on production metrics (COGS, yield, etc.).

Med Device Compliance:

• Follow fundamental industry standards, design requirements and test strategies which apply to regulatory requirements.
• Independently create or refine engineering documentation, such as the Design History file.
• Follow R&D procedures like design controls and risk management, per the Quality Management System.

General Responsibilities:

• Under minimal supervision, work with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.
• Quickly process and assimilate procedures, policies, processes, systems, and technology required.
• Work on complex problems, applying advanced experience and learnings.
• Demonstrate ownership and prioritize work with minimal supervision.
• Works as key member of the team, collaborating with others and solidifying relationships.
• Support multifunctional teams to and execute segments of projects through the design, development, and launch process.
• Deliver high quality results with passion, energy and drive to meet business priorities.
• Collaborate with cross-functional teams to build partnership to achieve business objectives.

PREFERRED QUALIFICATIONS: What you will need (strongly desired):

Technical Skills:

Technical ability to develop and optimize designs for medical device assemblies, incorporating DFM principles and clinical feedback and knowledge.

• Ability to communicate basic plans and technical information to team members, leaders, and project managers
• Technical knowledge in creating product test fixtures and developing test methods for verification and validation activities
• Fundamental knowledge and understanding of engineering practices, tools, and design principles within a regulated environment.
• Demonstrated ability to influence and drive results through others.
  

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.