Position Overview:

CoreLink Surgical is one of the fastest-growing, privately owned, medical device companies in the US. We design, manufacture, and distribute surgical implants and instruments for spinal fusion procedures (orthopedic and neurosurgical specialties). CoreLink’s unique vertical integration provides it a competitive advantage in quality, cost, customization, and speed to market of its products.

Principal Duties and Responsibilities (Essential Functions):

• 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 major, complex new product development projects. Participate in a cross-functional team throughout the project lifecycle, from concept to launch. Participate in the development of project plans, project management, and key deliverables.
• Coordinate with Marketing and Sales to define customer needs. Engage surgeons and KOL throughout the conceptualization and development phases. Participate in development sessions and actively participate in cadaver labs with surgeons to obtain critical project input.
• Conceptualize new designs of spinal implants and instruments to meet customer needs by incorporating human factors/usability engineering in the design process. Generate models and drawings using GD&T as well as industry and company standards. Collaborate with manufacturing and external vendors to develop models and drawings and apply DFM principles.
• Create rapid prototypes, working metal prototypes, and proof of concepts. Evaluate the performance and feasibility of early concepts in cadaveric labs and by conducting design of experiments – such as mechanical performance evaluations and other simulated surgical environments.
• Participate in risk management activities (e.g. dFMEA, pFMEA) and design activities such as Design Input, Design Output, Design Verification, Design Validation, and Design Transfer. Participate in Design Reviews and DHF documentation.
• Support Regulatory submissions, such as 510(k), from a technical standpoint.
• Assist Quality/Regulatory in the review of complaints and non-conformances. Support technical investigations, CCR, NCR, and CAPA.
• Develop novel innovations for inclusion in IP Portfolio. Support the launch of NPD projects with Freedom to Operate – FTO. Assess the competitive landscape in support of projects.
• Collaborate with Sales and Marketing to develop technical tools, training programs, and marketing collateral.
• Provide technical supervision, coaching, and mentoring to less senior engineers and technical personnel.
• Participate in and contribute to the strategic planning process by providing insightful input based on industry knowledge and experience.

Qualifications & Skills:

REQUIRED:

• Bachelor’s degree in Mechanical Engineering (preferred), Biomedical Engineering, Material Science, or another relevant technical discipline. A Master’s degree is preferred.
• At least ten years of hands-on development of complex mechanisms. Design of medical devices (i.e. Spine, Orthopedics, Trauma) models and implant/instrument systems is preferred.
• Excellent mechanical/mechanism design aptitude 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 with the designing and programming of structures for additive manufacturing. Experience using 3D Expert, EOS Print, Materialise Magics, or Within Medical software is a plus.
• Experience with design controls and regulations used in the development of medical devices is preferred.
• Experience working per ISO 13485 and 21 CFR Part 820, specifically as the manufacturer of record of implantable devices.
• Capable of performing and leading 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 the development of concepts, designs, and improvements of existing products.
• Working knowledge of Intellectual Property including but not limited to: Patents, Trademarks, and Trade Secrets.
• Must be flexible, willing to work independently or in cross-functional teams, and be 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 are a must.
• Self-starter, proactive, and accountable. Must be able to motivate self and others with alignment to company goals. Must lead by example and possess strong work ethics.
• Ability to create procedures, work instructions, and forms to ensure compliance with regulatory requirements.

PREFERRED:

A Master's Degree in Mechanical Engineering, Biomedical Engineering, or Material Science is preferred.

Great Benefits!

• Benefit Eligibility is immediate, enroll on day one of employment.
• Robust 401k plan with 3% employer contribution, no minimum employee contribution required.
• 9 Paid Holidays and Paid Vacation time
• Health / Dental / Vision Insurance
• Short / Long-Term Disability Insurance
• Relocation assistance
• Professional development assistance
• Tuition reimbursement, and more!

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.

Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.