Sr. Mechanical Engineer (Must Have Medical Device & SolidWorks)

Essential Job Functions

• Participates as a team member on product design teams and performs related design functions; including equipment design and trouble shooting, analysis, and technical writing.
• Analyzes problems in design, process, and test development. Recommend/implement solutions.
• Prepares and presents oral and written project updates and technical discussions.
• Provides technical support/guidance on components, materials, methods, systems and equipment.
• Develops physical and functional test requirements to ensure specifications are met.
• Writes and approves protocols and reports.
• Manages testing outlined in protocols and test methods.
• Manages/develops validation studies on equipment and processes.
• Plans and coordinates engineering test builds.
• Maintains a professional working relationship with internal and external customers and support staff.
• Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.
• Understands and follows company procedures and regulatory requirements.
• Participates in and provides input to training on department and division procedures and policies.
• Develops and implements procedures/policy.

Basic Qualifications

• 3 years of Solidworks® experience recommended. Solidworks® Certification preferred.
• Strong hands-on experience designing, building, and testing electro-mechanical systems.
• Programming experience with the ability and desire to learn new languages as needed.
• Working knowledge of digital and analog I/O.
• Ability to manage multiple concurrent projects.
• Ability to make and present engineering decisions.
• Strong “soft skills” i.e. the ability to work a wide range of personalities in a team setting required.
• Technical writing skills required.
• Oral and written presentation skills required.

Additional Desirable Qualifications, Skills, and Knowledge

• Experience designing automation equipment (panel layout, component integration, schematic design, safety, etc.).
• Experience with machine controls (PLCs, HMIs, PID controllers) and motion (linear actuators, stepper motors, etc.).
• Experience designing with pneumatics (solenoid valves, cylinders, actuators, regulators, etc.).
• Programming Language fluency: Ladder Logic, LabVIEW, VBA, G-Code and C/C++ a plus.
• Experience utilizing rapid prototyping in the design process.
• Experience with a variety of sensing and measurement technologies (thermocouples, photoelectric, vision, laser, etc.).
• Hands-on machining/fabrication experience a plus (mill, lathe, welding, etc.).
• Familiarity with a variety of manufacturing processes (machining, injection molding, additive manufacturing, sheet metal, welding, etc.).
• Experience in a manufacturing environment a plus.
• Experience in product verification via test equipment development and equipment validation (IQ/OQ/PQ) within an FDA regulated or other regulated industry (i.e. bio-tech/pharma, aerospace, etc.).
• Working knowledge of serial communication (RS232, RS485) is a plus.
• Experience interfacing with documentation control systems.

Education and/or Experience

• Bachelor's Degree in engineering plus 3-5 years (Master’s degree plus 2-3 years) of engineering experience in design and analysis within the medical device or another design-intensive industry.

Physical Demands

• While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.
• The employee frequently is required to talk and hear.
• The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.