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Sr. New Product Introduction & Manufacturing Engineer

About True Digital Surgery®

With a nearly two-decade legacy of creating cutting-edge medical devices, True Digital Surgery® is advancing its innovative 3D surgery digital platform through the integration of optics and robotics with augmented reality and machine learning that result in life-extending outcomes for both surgeons and patients.

 

SUMMARY

The Senior New Product Introduction (NPI) / Manufacturing Engineer (Mfg Eng) will function as a key member of the Operations team that ensures an orderly transition from R&D to Operations. The Sr NPI / Mfg Eng will be responsible for new product introduction, processes, tooling, test equipment and automation for both new and existing products. The Sr NPI / Mfg Eng will also be responsible for continuous process improvement (CPI) of our 3D visualization and guidance systems for microsurgery as it relates to manufacturing operations. Key system components include 3D imaging, optics, illumination, embedded processing, robotics, displays, mobile medical cart, system cables including high speed serial interfaces, power subsystem delivery, and grounding solutions. We need a dynamic, well-organized technical self-starter who can lead major initiative with minimal guidance. The selected individual will need to be a technical leader with the ability to establish a collaborative rapport with various stakeholders in Engineering, QA, Regulatory, Operations and Customer Service.  In addition to the orderly transition of new designs from R&D to Operations, the Sr. NPI / Mfg Eng will assist resolving manufacturing first pass yield issues, installed base technical service complaints, parts obsolescence and root cause analysis for product quality issues.  In addition to internal stakeholders the Sr NPI / Mfg Eng will interface with strategic suppliers and contract manufacturers, and propose solutions to satisfy the various needs of the Operations organization.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Manages an orderly transition of new designs from R&D to Operations
  • Participates in Product Development, working closely with Marketing, Engineering, and Manufacturing to identify Quality, Customer Satisfaction, Manufacturability and Serviceability issues and insures these items are designed into the product at every step of the product development process (design, prototyping, early production, and full production stages of product life cycle)
  • Project planning, product release in MRP, assembly instruction development, manufacturing process validation, tooling, fixtures, test equipment, automation, labeling and packaging for both new and existing products
  • Drives low cost and second source initiatives in product design, parts sourcing, and manufacturing
  • Works closely with Sustaining Engineering and Quality teams to ensure:
    • Defects are systematically logged into the Quality system and are properly tracked to completion
    • Perform root cause analysis and recommended resolution of product first pass yield issues, performance or quality shortfalls at TDS, strategic suppliers and/or contract manufacturers
    • Assessment of Alternatives for End of Life (EOL) components
    • Identify and support Continuous Product Improvement (CPI) initiatives of released products
  • Identifies technical problems and provides innovative and creative solutions
  • Completes test activities with robust documentation through validation plans and verification results
  • Generates detailed, high quality technical documentation to capture and communicate with cross functional teams
  • Works closely and collaboratively with the company’s Engineering, QA, Regulatory, Operations and Customer Service personnel to achieve objectives 
  • Shares technical knowledge with others on the team
  • Supports the Mfg Mgr with production planning and execution of an efficient manufacturing workflow
    • Supports daily standups where needed to resolve blockers or impediments to manufacturing progress
  • Other duties as assigned by the VP of Operations and PM

 

REQUIRED EDUCATION/EXPERIENCE

  • BS Degree with 10+ years of experience or MS Degree and 7+ years of overall experience (preferably EE degree) in a high technology company
  • 5+ years of NPI and/or Manufacturing Engineering
  • 2+ years of Project Management experience
  • 5+ years of experience working within a Quality Management Systems (QMS)
  • Experience with MRP and supplier management
  • Advanced skill set with MS Office (Word, Excel, PowerPoint), Visio, SolidWorks, MS Project, Test Automation

 

REQUIRED COMPETENCIES

To perform the job successfully, an individual will demonstrate the following competencies:

  • Manufacturability, Serviceability
  • System test, HW and SW trouble shooting skills
  • Strong technical documentation and writing skills
  • Supply Chain and Contract Management oversight (technical interface to strategic suppliers)
  • Development and evaluation of tools, fixtures and Special Test Equipment (STE)
  • Strong organizational and communication skills
  • Proficient engineering problem solving skills
  • Strong interpersonal skills with the ability to work collaboratively with others in a team environment

 

DESIRED COMPETENCIES

To excel in this position, an individual would benefit from the following competencies.

  • Optics Design (Microscopes), Embedded Computers, 3D Image Processing Techniques, High Speed Serial Interfaces (USB 3.0) or other, Custom Cable Design (including high speed serial interfaces)
  • Experience in the medical device (FDA) or other highly regulated industry is preferred
  • System power and grounding
  • Product safety and EMC testing
  • Thrives on change and adapts to leader initiated changes

 

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Organizational Support – follows policies and procedures, provides necessary support to organization.
  • Planning/Organizing – uses time efficiently, organizes work in an orderly fashion
  • Attendance/Punctuality – is consistently at work and is on time
  • Dependability – responds to management direction, commits to long hours of work when necessary to reach goals, completes tasks on time or notifies appropriate person with an alternate plan
  • Professionalism - approaches others in a tactful manner and reacts well under pressure and follows through on commitments
  • Safety and Security – observes safety and security policies and procedure and uses equipment and materials properly

 

Physical Requirements

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 the essential functions.

While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 50 pounds and frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include color, distance and close vision.

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 the essential functions.

While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate.

Benefits:

We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment

To Apply:

To respond to this opportunity, please apply through this ad.

For more information about us, please visit www.truedigitalsurgery.com

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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