Design Engineer

Position Overview:

As the Design Engineer, you will be responsible for carrying out a variety of engineering duties including designing, researching, and prototyping new products.

Responsibilities will include but are not limited to:

• Execute activities associated with the design and development of new products, specialty, and custom products, and sustaining work using GMP, the company’s design control procedure, and quality management system.
• Responsible for leading minor or line addition new product development projects. Lead a cross-functional team throughout the project lifecycle, from concept to launch. Ownership of the project plan, project management, and key deliverables. Serve as team member or major, complex projects providing design and technical support as directed by Project Leader or more senior colleagues.
• Participate actively with Marketing and Sales to define customer needs. Engage surgeons and KOL throughout the conceptualization and development phases. Lead development sessions and actively participate in cadaver labs with surgeons to obtain critical project input.
• Conceptualize new design of spinal implants and instruments to meet customer needs and by incorporating human factors/usability engineering in the design process. Generate models and prints using GD&T (Geometrical Dimensioning and Tolerancing). Collaborate with manufacturing and external vendors to review prints and apply DFM (Design for Manufacturability) principles.
• Create rapid prototypes (e.g. SLA, FDM), metal prototypes, and proof of concepts. Evaluate the performance and feasibility of early concepts in cadaveric lab and by conducting design of experiments – such as mechanical performance evaluation and Sawbone simulation.
• Participate in risk management activities (e.g. dFMEA, pFMEA) and lead design activities such as Design Input, Design Output, Design Verification, Design Validation, and Design Transfer. Responsible to perform the Design Reviews and create the Design History Files documentation. Serve as technical leader within the product development team.
• Support Regulatory submissions, such as 510(k), from a technical standpoint.
• Lead the cleaning, packaging, and sterilization validation activities. Manage the development of instrument trays and BOM.
• Participate in Material Review Board (MRB) and assist Quality/Regulatory in review of complaint and nonconformance. Support technical investigations, CCR, NCR, and CAPA.
• Collaborate with Sales and Marketing to develop technical tools, training programs, and marketing collateral.

Required Education and Experience:

• Bachelor’s degree in Mechanical Engineering (preferred), Biomedical Engineering, or other relevant technical discipline. Master’s degree is preferred.
• At least three years of hands-on product development with design control and regulation experience developing medical devices (i.e. Spine, Orthopedics, Trauma) models and implant / instrument systems.

Have individual skills and abilities in the following areas:

• Must be flexible, willing to work independently or in cross-functional teams, with proven mentoring and leadership skills and able to adapt to the dynamic needs of a small company. Must be able to work and communicate well with others in a diverse team environment. Excellent written and oral communication skills.
• Self-starter, proactive, and accountable individual able to motivate self and others with alignment to company goals. Must lead by example and possess strong work ethics.
• Excellent mechanical/mechanism design aptitudes, and problem solving/analytical skills. Must possess work experience using statistical tools for analysis and sample size selection.
• Must possess a good understanding of manufacturing processes (e.g. milling, turning, wire-EDM, welding). Must have proven hands-on technical skills in Design for Manufacturability (DFM) and Geometric Dimensioning and Tolerancing (GD&T). Must have experience prototyping, developing proof of concepts, and performing Design of Experiments.
• Proficiency using Computer Aided Engineering/Design (CAE/CAD), with SolidWorks preferably. Hands-on experience with Finite Element Analysis (FEA) is desirable.
• Experience working per ISO 13485 and 21 CFR Part 820, specifically as the manufacturer of record of implantable devices.
• Capable of performing tasks and duties in support of the development of assigned Line Extensions, Product Upgrades, Specials, and New Product Development (NPD) projects using Regulatory compliant practices, software, tools, and procedures. Must be able to develop project plans and drive projects to completion according to the timeline and with accountability.
• Experience in interactions with Sales, Marketing, Surgeons and industry professionals in development of concepts, designs, and improvements for existing products.

Position Type/Expected Hours of Work

• This is a full-time position. Days and hours of work follows but is not limited to the core corporate hours Monday through Friday, 8a.m. to 4:30 p.m.

Travel

• Minimal travel is expected for this position.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.