Position: R&D Senior Mechanical Engineer – Senior Level

Location: Sparks, MD

Duration: 12 Months

Total Hours/week: 40.00

1st Shift: 8am - 5pm

Client: Medical Device Company

Level Of Experience: Senior Level

Department: R&D Hardware Engineering

Reports To: Alyssa Shedlosky, R&D Manager

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

 

 

Job Description:

The statements below are intended to describe the general nature and level of work being performed by associates assigned to this job.

This job description is not intended to be an exhaustive list of all responsibilities, duties, and skills required of associates so classified.

Responsible for mechanical engineering design and development efforts on multi-disciplinary projects to produce technically sound medical diagnostic instrumentation.

Participates in the project planning and ensures that schedule milestones are met.

Mechanical Engineering is responsible for designing and developing components, mechanisms, systems and finished products or equipment.

Demonstrates advanced knowledge of Mechanical Engineering and its application in solving moderately-complex mechanical problems.

Demonstrates advanced understanding of internal and external customer or business needs.

Works independently to create design of multiple components, systems or devices.

Independently tests, analyzes and solves advanced technical problems.

Applies advanced statistical techniques and utilizes design of experiments.

Has in-depth experience, knowledge and skills in own job family.

Applies knowledge and skills to a wide range of standard and non-standard situations.

Works independently with minimal guidance.

Usually determines own work priorities. Acts as a resource for colleagues with less experience.

 

Duties and Responsibilities:

Responsible for the detail design and engineering of automated mechanical or electromechanical systems and subsystems.

Develop design input (specifications) for mechanical systems in instrumented products.

Apply engineering principles, analytical skills, and empirical methods to develop

statistically robust designs.

Design products to meet cost targets. Prepare cost estimates of mechanical components

and assembly labor.

Accurately estimate work effort for assigned engineering tasks. Contribute to and

participate in technical reviews. Assess the ability of proposed designs to meet specified

requirements, including manufacturability.

Assist in test planning and development to ensure instrument systems and sub-systems

conform to requirements on reliability and robustness.

Complete assignments within established schedules and budgets.

Interact closely with electrical, systems, software, and test engineering functions to

develop comprehensive solutions to design problems.

Generate engineering documents, drawings and specifications to internal and industry

standards, including ASME Y14.5M-1994 Dimensioning and Tolerancing.

Conform to the requirements of ISO 9001 and CGMP standards for the design and

development of medical devices.

 

Knowledge And Skills:

Demonstrated application of engineering principles and techniques, including heat transfer, fluid mechanics, and kinematics and dynamics as applied to machine design.

Demonstrated knowledge of creating requirements, prototyping, conducting experiments, analyzing data, and writing reports for medical or scientific diagnostic equipment.

Strong technical judgment and problem solving skills.

Five years’ experience with solid modeling CAD applications with large assemblies in team environments.

SolidWorks experience required. Applied usage of Geometric

Dimensioning and Tolerancing (GD&T) preferred.

Three years’ experience with designing for complex automation systems, including but not

limited to machined metal, sheet metal, and metal frame weldments.

Experience with CAD Data Management or PLM management of CAD data.

Experience with estimating time for engineering tasks and reviewing designs.

Usage of Design for Six Sigma or similar robust process development methodologies preferred.

 

Minimum Qualifications:

Bachelor’s Degree in Mechanical Engineering with at least five years relevant experience, or Masters with at least three years of experience

Must possess product development experience in a regulated industry.

Medical device and/or pharmaceutical industry experience, with a strong record of

delivering products to market or developing commercially viable technology is preferred.