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Senior Product Development Engineer

SUMMARY

Under minimal supervision, primarily responsible for the design and development of new spinal products/product families and/or the enhancement of existing products. Involved in creating designs, modeling and drafting, utilizing a 3D CAD system. Other responsibilities include assisting in the development process with Marketing, Purchasing, Manufacturing, Quality, and Regulatory to help manage the project deliverables from conceptualization through full market launch.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Research, develop, and design spinal implants & instruments in accordance with FDA and ISO requirements—New Product Development as well as maintenance of existing legacy systems.
  • Lead identification and timely execution of complete product development process and project deliverables, including concept design, testing, design finalization, verification/validation activities, transfer, and launch support.
  • Execute development activities of multiple line extensions and special instrument modifications in an abbreviated schedule simultaneously.
  • Create designs using CAD (SolidWorks) intended for both subtractive and additive manufacturing methods. Generate 3D part files, 3D assembly files, & 2D technical drawings.
  • Write protocols, execute, analyze test data, and generate reports to verify or validate that designs meet functional and performance specifications, including interactions with outside testing facilities.
  • Generates and manages the Change Order process for initial release & revision of device-related changes, including potential impacts on current design inputs, risk, and relevant controlled documents in the system Design History File.
  • Generates and manages the Change Order process for initial and updated revisions of appropriate Quality Management System documents and processes.
  • Identify and collaborate on the improvement of company and group policies, capacities, and direction.
  • Primary interface with ALL customers (Surgeons, Distributors, FDA, Manufacturers, Consultants, Etc.) to discuss design inputs, functional instruction, and current challenges for new product development as well as legacy systems.
  • Communicate effectively across cross-functional teams to identify and ensure project team and senior management are aware of upcoming milestones and risks/issues.
  • Utilize in-house rapid prototyping and interface with suppliers to provide support during the manufacturing process.
  • Review and approve product Inspection Standards, overlays, and gauges in collaboration with the Quality department.
  • Competently provide technical assistance to other areas of the organization including, but not limited to, Sales, Marketing, Quality, Regulatory, Purchasing, Sales Support and Executive Management.
  • Routinely conduct static and fatigue stress analysis on developed designs using FEA, including interpretation of results.
  • Collaborate & offer background, knowledge, & expertise with other Group staff.
  • Follow organizational & group guidelines, procedures, protocols.
  • Work with clients and patent counsel to prepare invention records and assist in the patent submission process.
  • 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.

SUPERVISORY RESPONSIBILITIES

Not Applicable

QUALIFICATIONS

  • Experience and Proficiency with CAD software required (SolidWorks preferred).
  • Full working knowledge & experience with product development cycle and phased/gate approach of small to medium projects.
  • Knowledge of general manufacturing processes, and familiarity with common materials and practices to produce medical implants and instruments. Experience with Additive Manufacturing preferred.
  • Experience with GD&T, stack-up analysis, and mechanical testing.
  • Experience and knowledge relevant ASTM, ISO, FDA standards, regulations, guidelines.
  • Successful with autonomy of responsibility in addition to a team environment.
  • Be adept and flexible to manage multiple tasks at once while keeping to the set schedule of each task.
  • Capable of presenting and sharing information with management, surgeons, and/or field personnel when requested (PowerPoint skills preferred).
  • Capable of presenting and sharing information with management, surgeons, and/or field personnel when requested (PowerPoint skills preferred).
  • Proficiency in science and engineering principles including physics, algebra, statistics, the ability to understand and solve technical problems, collect and analyze data, draw valid conclusions and communicate findings.
  • Experience with Project Management planning preferred (MS Project, Smartsheet, etc.)
  • Competency in the identification and investigation of issues, determination of appropriate solution, and implementation to resolve the problem.

EDUCATION and/or EXPERIENCE

  • BS in Mechanical Engineering or Biomedical Engineering or equivalent
  • 5+ years of experience required.
  • Product development experience required.
  • Spinal or Orthopedic Implant design experience preferred.

PHYSICAL DEMANDS 

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
  • While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand, walk, use hands to finger, handle, or feel and reach with hands and arms.  The employee must occasionally lift and/or move up to 25 pounds.

WORK ENVIRONMENT 

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
  • Working environment is typical of an office environment. The noise level in the work environment is usually moderate.
Buyer

SUMMARY:

This position is responsible for purchasing replenishment of component and finished goods of instruments and implants for assigned product lines. The Buyer will also assist with the purchase of prototypes, pilot production and full launch quantities for new product launches. The Buyer will ensure instruments and related components are procured through qualified sources and are delivered within set schedules. This individual will also be responsible for execution of procurement strategies, including supplier consolidation, kanban, VMI, etc. as directed. The Buyer will assist with supplier management duties and will monitor supplier performance based on quality, delivery, and lead-time metrics. Strong analytic and problem-solving abilities, negotiation skills, project management, consensus building, interpersonal relationship skills, and risk management as it pertains to supply chain are important for this position. The individual in this position will provide management with timely information on program performance, material acquisitions and execution to technical, cost, and schedule objectives.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Initiates and monitors open purchase orders to ensure timely receipt and to maintain inventory target levels.
  • Assists in negotiating pricing & delivery as well as supplier selection and management.
  • Ensures consistent, high-level performance of suppliers to delivery schedules, commitment, and performance based on the terms and conditions of the negotiated contracts.
  • Develops and maintains a good working relationship with suppliers in order to assure the implementation and completion of the production plan.
  • Supports development activities with direct purchases of raw materials, components & instruments required for prototypes, pilot production and initial launch requirements.
  • Provides support for engineering change orders, non-conformances, and accounting/receiving discrepancies.
  • Serves as core team member for product launches, set builds, and/or other special projects as assigned.
  • Assists with implementation of procurement strategies, including supplier consolidation, kanban, VMI programs, as well as identification of alternative procurement sources to ensure the long-term, cost-effective supply.
  • Assists in the management of inventory levels, schedules, and availability of selected items to meet build & launch schedules.
  • Provides liaison services between suppliers and various departments within the company, including R&D, Quality, Regulatory, etc.
  • Assists with negotiation of pricing & delivery, as well as supplier selection as directed.
  • Assists with return to vendor process (RTV) and RTV reconciliation.
  • Works with Accounts Payable on resolution of problem invoices or supplier billing disputes.
  • Performs other duties as assigned.
  •  

SUPERVISORY RESPONSIBILITIES

Not Applicable

QUALIFICATIONS:

  • Energetic, self-motivated individual able to work in fast-paced, schedule-based environment; must be able to multi-task and proactively solve problems
  • Ability to work in a team environment in a support/service capacity.
  • Negotiation, problem-solving, and financial analysis skills.
  • Strong verbal and written communication skills
  •  

EDUCATION AND EXPERIENCE:

  • BS Engineering Degree, preferred, or significant technical experience with degree in Business, Operations Management or significant relevant experience.

    • Minimum of 0-3 years’ experience in Purchasing or Operations in a Manufacturing environment
    • Background using ERP systems preferred.
    • Experience and understanding of manufacturing processes common to orthopedic implants and instruments, and commercialization of new product – Preferred
    • Travel is less than 10%.

CERTIFICATES, LICENSES, REGISTRATIONS

Not Applicable

EXEMPTION

Exempt

PHYSICAL DEMANDS 

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. In addition, the employee should be able to stand, walk, use hands to finger, handle, or feel and reach with hands and arms. In addition, the employee must occasionally lift and move up to 25 pounds. 

WORK ENVIRONMENT 

The work environment characteristics described here represent those an employee encounter while performing this job’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. The working environment is typical of an office environment. The noise level in the work environment is usually moderate.

 

Choice Spine was started in 2006, when the two co-founders, Marty Altshuler and Rick Henson, decided to take their medical device distributorship and turn it into a full medical device company. In the 17 subsequent years, the company has expanded from a handful of specialized products to the design, development, and commercialization of a full portfolio of hardware and biologic solutions addressing nearly all degenerative and emergent spinal care needs. Currently, Choice Spine has nearly 70 team members who work every day to “improve people’s lives by doing spine the right way” in 35 US states and 5 International markets.

Our “PART B” culture is at the heart of who we are and how we operate.  Choice Spine team members embody “PART B” through the following behaviors:

 

  • Positive Attitude

  • Accountability

  • Responsiveness

  • Trustworthiness

  • Be a Team Player

Choice Spine strives to offer not only a competitive compensation and benefits portfolio but an operating environment that fosters ownership and autonomy for our team members. Our mission of “Improving People’s Lives by Doing Spine the Right Way” provides that shared responsibility to do all we can to deliver the best solution possible to our surgeon partners so that they can deliver optimal care to their patients and achieve the best possible outcome for them in their situation. Our team-oriented environment emphasizes “collaboration” and “commitment” to achieve our mission.

Some Benefits of Working at ChoiceSpine:

  • Competitive Compensation and Bonus Opportunities for all Employees
  • Medical (HSA and PPO Plans)
  • Dental
  • Vision
  • Teladoc
  • 401k Plans and Employer Match (both Traditional and Roth Options)
  • Paid Time Off Program
  • Short-term Disability (Company Paid)
  • Long-term Disability (Company Paid)
  • Employee Assistance Program
  • Tuition Reimbursement
  • Compressed Workweek/Flexible Friday Afternoon Scheduling
  • For several consecutive years, ChoiceSpine was selected by its employee base as a Top Workplace

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