Design Engineer

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job Role: Design Engineer

Location: Blue Ash, OH

Duration: Long term

Job Description:

We are looking for profiles from Medical device industry( Medical equipment manufacturing companies)

Responsibilities

• Design and Development experience in Medical devices.

• Apply knowledge of general engineering principles, materials, DFMA & reliability to achieve product design requirements.

• Work one-on-one with customer stakeholders to identify procedure and/or product opportunities and evaluate potential technical solutions.

• Interpret customer & marketing input to define technical design requirements and maintain idea notebooks.

• Develop free-body diagrams, calculate stress & strain values, and formulate tolerance stack-ups.

• Mechanical product design experience is required.

• Experience in a FDA-regulated environment is highly preferred.

• Experience designing, developing, and launching medical products is highly preferred.

• Strong mechanical design and analysis skills, including an understanding of mechanical subsystem interface to overall system design is highly preferred.

• Experience developing and utilizing 3D CAD models, FMEA, GD&T, tolerance analysis, FEA, DOE’s, simulated use testing, and statistical analysis is highly preferred.

• Experience with root cause analysis is highly preferred.

• Strong understanding of design control activities and experience developing/executing design plans, design verification and validation are highly preferred.

• Experience with general design engineering and Design for Manufacturing (DFM) principles, Design to Cost (DTC), Design for Assembly (DFA), component manufacturing processes, tooling methodologies, material properties, and regulatory compliance preferred.

• Experience translating high-level customer needs into technical options and analyzing the trade-offs and business impact is preferred.

• Experience designing test procedures, coordinating tests, analyzing results, and developing written reports preferred.

• Design engineering principles3D CAD software proficiency (UG is a plus) and Design of experiments (DOE)

• Geometric tolerance & tolerance stack-up analysis (GD&T, Stack-up) and Free-body & stress-strain analysis & FEA (finite element analysis)

• Design analysis software, (e.g., Mathcad, MATLAB, Crystal ball)

• DFMA (design for manufacturing and assembly) principles

• NPI phase gated process, including design review, validation, and release to production activities.

• Maintain weekly project tracking sheet and schedule follow up design meetings.

• Work closely with Sustaining Engineers in developing new processes, tooling and manufacturing concepts that will meet customer expectations on cost, quality and delivery.

• Execute validation and qualification (IQ/OQ/PQ) protocols for new product, equipment, tooling, and processes, Physical Test Method Validation, Developing test fixtures and Work with SOP's

• Formulate tolerance stack-ups; Calculate stress & strain values; Develop free-body diagrams.

• Assist in developing & monitoring project plan, budget, contingency plans & work estimation.