Senior Engineer, Product Development

POSITION PROFILE

The role will play a crucial role in the medical device team, responsible for conceptualizing, designing, and developing additively manufactured prototypes and products that will ultimately enhance patient care. The ideal candidate will have a deep understanding of various design software, technical aptitude in additive manufacturing technologies, proficiency in CAD modeling and rapid prototyping techniques, as well as a strong background in materials and manufacturing processes. Collaboration with cross-functional teams, adherence to regulatory standards, and a passion for innovation and problem-solving will be essential to successfully contribute to the team's goal of improving patient outcomes and revolutionizing the medical device industry.

Job Duties and Responsibilities

• Ideate, design, iterate, and evaluate product concepts quickly and effectively via prototype builds, laboratory testing, and/or computer simulations.

• Meet with surgeons, simulation specialists, inventors, and other medical personnel to develop design requirements based on user needs and product function; translate design requirements into concepts/solutions.

• Build prototypes using both additive manufacturing processes and more traditional methods such as machining and silicone molding as required.

• Supports onsite additive manufacturing both internally and for customer sites while adhering to Ricoh's quality management system.

• Conduct preventative maintenance on manufacturing equipment; support 3D print center upkeep.

• Develop test methods, design/build fixtures and systems for testing, and generate/process/analyze advanced engineering data to meet design specifications.

• Provide technical expertise and support to customers through design reviews, helping them understand the accuracy, feasibility, and manufacturing requirements of their medical device designs ensuring compliance with industry regulations and quality standards.

• Work directly with management, engineers, production techs, and customers to develop design input guidelines.

• Work directly with internal additive manufacturing team for prototype and development of product.

• Conduct detailed reviews of designs, test methods, requirements, specifications, etc. and effectively communicate technical information in written/verbal forms.

• Confers with cross-function teams (by way of example and not exclusion Biomedical Engineering, Production, Business Development, and Regulatory/Quality); accepts and completes tasks as assigned.

• Participate in the evaluation of new concepts presented to Ricoh 3D for Healthcare by surgeons or other Ricoh 3D for Healthcare employees.

• Responsible for completing design control documents, quality system documents and creating the DHF for FDA review through the 510(k) process.

• Contributes to the investigation of production problems and product quality issues, collaborates with other functional areas to identify root cause, and recommend corrective action/countermeasure, prepares action plan, manages solution implementation, and summarizes and reports results, updating the risk management files with new risk mitigation solutions.

• Encourages and builds positive relationships, communicating effectively with all co-workers and vendors.

• Supports the preparation of additional data/information requested by regulatory department and drafts internal responses to all such requests, i.e., FDA 510K submissions.

• Performs other duties as assigned.

QUALIFICATIONS (Education, Experience, and Certifications)

• BS in Mechanical Engineering, Biomedical Engineering, or equivalent strongly preferred or equivalent experience in medical 3D printing or additive manufacturing; degree or certificate in 3D printing related field or industry-specific certifications are desirable.

• 5+ product design experience

• Experience in a QMS or FDA regulated environment producing medical devices preferred.

• Proficiency using GD&T and 3D CAD packages such as Fusion 360, Rhinoceros 3D, Creo, Catia, SOLIDWORKS, Autodesk Inventor, etc. Minimum of 2 years required.

• Familiarity with design for additive manufacturing and production standards is preferred such as ASTM, ISO 9000, ISO 14971, ISO 13485, and 21CFR.

• Experience with standard business software.

• Experience in an Additive or 3D printing environment is required.

• Prior experience with customer-oriented responsibilities strongly preferred.

Knowledge, Skills and Abilities

• Proficient in the Design Control process with knowledge of tracing DHF documents to product requirements including Design Input / Output / Verification / Validation.

• Ability to present information and respond to questions from groups of managers, customers, regulatory agencies, and sales representatives.

• Engineering design knowledge of materials selection, simulation and modeling, process optimization, gathering, translating, and developing customer requirements in functional mechanical solutions.

• Understanding of additive manufacturing processes and design for additive manufacturing.

• Excellent verbal and written communication skills and ability to understand technical documentation.

• Excellent customer service skills with the ability to guide customers and develop and maintain strong customer relationships by responding promptly to clients' needs. Provides follow-up communication to ensure client satisfaction.

• Competency in the identification and investigation of issues, determination of appropriate solutions, and implementation to resolve the problem.

• Ability to work with a variety of post processing technologies and products such as Vapor (IPA, acetone, etc.) finishing/smoothing, support removal, general part cleanup using hand tools, familiarity w/ basic GD&T (geometric dimensioning & tolerancing) tools, vibratory/ultrasonic cleaning, and grinding/sanding.

• Ability to execute activities aligned to project plans.

• Ability to evaluate workflows and develop improvement strategies.

• The successful candidate will be project oriented with the ability to stay on task, but with considerable variety between tasks, while contributing to building a positive team environment

• Willingness to confidently adapt to a changing work environment, circumstances, and duties, despite stressful situations.

• Highly motivated; can handle multiple assignments and operate effectively in production environment.

• Strong problem-solving skills needed to resolve complex process, scheduling, and quality problems for which an established method is not clear or may not exist.

• Builds and manages relationships within the facility to acquire resources.

• Is well organized and uses time effectively.

• Ability to work in a high-performance culture with clear expectations of performance.

• Analyzes and presents any given subject in a clear, concise, and logical manner both orally and written. Interacts effectively with different audiences (e.g. internal management, external clients). Excellent presentation skills.

• Must be able to Multi-task.

• Must be Self-Motivated.

• Must be Enthusiastic.

• Must have Strong Work Ethic.

WORK CONDITIONS, MENTAL AND PHYSICAL REQUIREMENTS

• Work is performed in multiple types of environments including typical office and manufacturing.

• Requires careful handling of delicate parts.

• Requires regular communication with engineering manager and customer.

• Minor physical effort is required, which may involve long periods of standing, walking or similar activities

• Requires moderate dexterity - regular application of basic skills (calculator, keyboard, etc.)

• Occasional business travel may be required.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, skills, efforts or working conditions associated with a job.

Come Create at Ricoh:

If you are seeking a team driven by passion and purpose, come create with us at Ricoh. We are a team of information seekers and customer-obsessed collaborators who aspire to deliver the services, solutions, and technologies that empower business success. We are looking for talented, inspired individuals to join us to help drive high-performance team and our commitment to excellence.

Ricoh is an integrated solutions provider and partner that connects people and technology, creates outstanding customer experiences, and delivers innovation for businesses worldwide. We empower digital workplaces by enabling individuals to work smarter from any location and harness the power of information—how it is collected, stored, managed, and shared—to unlock the potential in every organization. We deliver services and technologies that inspire our customers’ success and guide them toward a better and more sustainable future. If you are seeking a purpose-driven and passionate team, come create with us, and help drive our high-performance culture of excellence into tomorrow.

Invest in Yourself:

At Ricoh, you can:

• Choose from a broad selection of medical, dental, life, and disability insurance options.

• Contribute to your financial security with Retirement Savings Plan (401K), Health Savings Account (HSA), and Flexible Spending Account (FSA) investments.

• Augment your education with team member tuition assistance programs.

• Enjoy paid vacation time and paid holidays annually

• Tap into many other benefits to enhance your health, wellness, and ongoing personal and professional development.

EEO/Affirmative Action Employer -- M/F/Disability/Veteran