Job Title: Design Engineer
Exempt
SCOPE:
The Design Engineer will develop and support innovative surgical devices, from concept to launch and beyond, with shared responsibility and shared reward. The role should understand user needs and requirements, balance individual product-level requirements with system-level requirements, resolve complex mechanical design issues, and commit to the highest product quality. Projects will include a mix of new product development, product improvements, and sustaining projects to mitigate challenges related to capacity improvements and supply chain. Responsibilities include developing, documenting, and validating new product designs, as well as improving existing designs to meet the needs of our customers.
ESSENTIAL JOB FUNCTIONS:
- Creates design concepts through vendors of rapid prototyping physical models (3D printing, machining, etc.)
- Creates intellectual property by brainstorming novel concepts, writing invention disclosures, and creating rapid prototypes
- Serves as lead technical designer, providing technical advice and mentoring the junior design engineers, working on cross-functional project teams to develop new, world-class surgical devices
- Performs engineering analyses of parts and assemblies (FEA, fatigue, manufacturability, FMEA, root cause analysis, DOE creation). Establishes and maintains systems for continuous improvement by capturing user feedback and other data to improve existing and new designs
- Creates and maintains engineering drawings to company and international drafting standards
- Supports the quality and regulatory processes
- Abides by the documentation for product development that aligns with the company's Quality System and meets or exceeds requirements of the FDA's 21 CFR Part 820 regulations and ISO 13485 standards
- Works within the non-conformance system to record discrepancies assists in the review of the non-conformance and to record the results of the Material Review Board (MRB) and associated activities
- Reviews device master records, history records and other quality-related documents for accuracy and completeness. Assists to perform first article inspections
- Performs testing of medical devices to replicate customer complaints for the evaluation of changes to existing and new product designs
- Designs for manufacturing and automation, sterilization processes and biocompatibility
- Assesses field reliability data and improves existing product designs as necessary
- Assists in the evaluation of customer complaints on existing product designs
- Participates in the evaluation of non-conforming product to assist in the improvement of existing and new product designs
- Assists in the activities of analyzing repairs for improvement to new and existing devices
- Under limited supervision, contacts customers and sales representatives to resolve technical and quality problems and may provide technical support
- Performs additional activities when needed or as defined by the management
PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Duties are performed while sitting at a desk, walking, bending, squatting, lifting, carrying, pulling and pushing within the office area and warehouse will be required as needed on a daily basis. Required duties include operating a computer frequently (about 85% of the time), reading, writing and communicating email correspondence (about 60%), and using a telephone (about 10% of the time).
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Job duties are performed in an office and wharehouse environment utilizing standard office equipment such as a computer, and telephone. The noise level in the work environment is usually low to moderate.
MINIMUM QUALIFICATIONS - The qualifications below are the knowledge, skills, and abilities required to do this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
KNOWLEDGE, SKILLS, AND ABILITIES:
- BS Mechanical Engineering, Biomedical Engineering, or Materials Engineering (or related science/engineering area)
- 5+ years of experience developing medical products. Experience with metals or reusable surgical instruments is a plus
- Must be highly capable using Solidworks. Skilled in mechanical design and use of CAD to create detailed 3D models and engineering drawings. Must be highly capable of using SolidWorks
- Experience creating rapid prototypes and mock-ups and evaluating designs via testing and rigorous analysis
- A passion for solving tough technical problems - Strong mechanical intuition and persistence to drill down to pinpoint root cause of problems, solving problems using fundamental principles
- Demonstrated ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements
- Proficiency using CAD to design parts and assemblies and to create specification drawings in a PDM environment; Solid works strongly preferred
- Hands-on engineering with the ability to work well in a team environment
- Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer
- Familiar and Comfortable with concepts of design input, design output, traceability, and risk analysis
- Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials and stress analysis (FEA); familiarity with statistics and design of experiments
- Experience designing plastic components and assemblies
- Excellent interpersonal and communication skills, both written and verbal, and ability to effectively communicate technical issues
- Familiar with phases of the product development lifecycle, including conceptualization, design, verification, validation, and transfer to manufacturing
- Proficiency in technical writing
TRAVELS
This position may require 10 to 20% of time to meet with customers.
NOTE: This job description in no way states or implies that these are the only duties or functions to be performed by the incumbent. Employees will be required to follow any other job-related instructions and to perform any other job-related duties/functions requested by their manager.
