Senior R&D Engineer

POSITION SUMMARY

ESSENTIAL FUNCTIONS OF THE POSITION

• Present data in technical Design Reviews.
• Develop and analyze statistical data and product specifications to ensure product quality.
• Maintain and increase professional and technical knowledge by on-the-job training, attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
• Assure product compliance to specifications through implementation of inspection criteria and procedures in operations processes. Drive quality and manufacturing improvements to ensure processes are in state of control.
• Participate in specifying and procuring equipment/tooling.
• Manage existing and/or establish new suppliers to help facilitate prototyping and engineering builds.
• Develop test methodology and fixturing for engineering evaluations.
• Perform R&D Engineering project-based assignments with adherence to the Quality Management System procedures and standards.
• Set-up pilot production of new products or product improvements to provide clinical, test, and validation samples.
• Support compliance with the company quality standards, FDA regulations and guidance, applicable EU Medical Device directives, applicable ISO standards, and other pertinent country specific medical regulatory requirements.
• Perform special projects and other duties as assigned.
• Assist in developing assembly/build processes and workmanship standards.
• Ensure compliance with design control procedures.
• Design and validate fixturing for manufacturing processes and assembly.
• Support Quality Management Systems assignments including auditing, root cause and corrective action analysis and perform receiving and in-process inspection assignments requiring product verification, documentation validation, and associated systems transactions.
• Assist in gauging and calibration activities, as necessary.
• Apply design and development experience toward enhancing existing products and introducing new products with innovative problem solving, a willingness to fail fast, pivot, and systematically iterate while taking ownership of R&D deliverables through completion.
• Initiate and/or maintain Design History Files (DHFs).
• Perform shelf-life testing (including protocols, test method validation, and reporting).
• Own the drafting, review, and approval of documents needed for the Design Control process including, but not limited to, drawings, purchasing specifications, BOMs, routers/Work Orders, Manufacturing Process Instructions (MPIs), Quality Inspections (QIs), First-Article Inspection (FAI) reports, FMEAs, Design Input and Output Matrix, protocols and reports, and biocompatibility assessments.

EDUCATION AND/OR EXPERIENCE

• Experience with Class II or Class III devices.
• Experience writing and performing design verification and validation protocols/reports.
• Strong understanding of quality systems, regulatory requirements, development, and manufacturing processes.
• Strong knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, 21 CFR 820, ISO 14971:2012, IEC 60601, ISO 13485, EN 62304, and IEC 62366) to Design Controls.
• Demonstrated knowledge of statistical methods and principles.
• Bachelor's degree in Engineering (focus in Biomedical or Mechanical engineering preferred) with a minimum of five years’ experience in a regulated industry; or an advanced degree with a minimum of three years’ experience in a regulated industry.

• Medical device start-up experience with successful product introductions or acquisitions.
• Design experience with injection molded parts.
• Intellectual property issued as the primary/contributing inventor or experience in filing invention records.
• Experience in testing early-stage product concepts in either animal or cadaver models.
• Six Sigma and Lean knowledge.
• Experience with spine products, surgical instruments, laparoscopic instruments, or endoscopic devices.
• Experience working with key opinion leaders in the field to identify market requirements, industry, and regulatory partners.

SKILLS, ABILITIES, AND CHARACTERISTICS

• Strong organization skills and workmanship standards, with a desire to have a well-maintained work environment.
• Proficiency with Project Management and organizational skills.
• Displays broad perspective and effective judgment.
• Ability to support multiple projects and balance priorities.
• Ability to work and excel within a fast paced and dynamic work environment.
• Ability to design with CAD software; SolidWorks preferred.
• Strong oral/written communication skills.
• A strong mechanical aptitude with a hands-on approach to mechanism and product design.
• Strong interpersonal skills.
• Ability to interact cross-functionally and proactively escalate issues with integrity to appropriate levels of management in the organization.
• Discipline for raising the bar of expectations and to challenge/seek opportunities for improvement with a critical and objective approach.
• Ability to work both independently and collaboratively.
• Tech savvy: proficiency in Microsoft Office applications and in mobile/cloud resources; comfortable learning new technical systems as needed such as Box, Zoom, and Slack.
• A can-do attitude and a willingness to explore ideas that are not necessarily their own.
• Ability to negotiate with multi-disciplinary teams.
• Demonstrates well-reasoned problem solving and data-driven decision-making.
• Statistical knowledge and experience with establishing sample sizes for engineering tests.
• Strong ability to apply metal and plastic manufacturing processes, including but not limited to, milling, lathe machining, EDM, coil winding, braiding, extrusion, reflowing, molding, bonding, ultrasonic welding, laser cutting, and laser welding.
• Ability to apply Medical Device Regulations to new product development.

PHYSICAL REQUIREMENTS/WORK ENVIRONMENT

• Potential exposure to bloodborne pathogens, pharmaceuticals, chemicals, needles, and sharps, and radiation (from x-ray / fluoroscopy and similar medical equipment).
• Mental Demand – Moderate to high degree of concentration due to volume, complexity, and/or timeliness of work. Must have the assertiveness to present elegant solutions to moderately complex problems and execute under a reasonable amount of pressure.
• When working in a home office environment, a dedicated office with minimal distractions which assures maximum privacy of computer screens to protect confidential and sensitive information is required; highspeed internet connectivity is required to work effectively.
• Work Environment –
  • Potential exposure to bloodborne pathogens, pharmaceuticals, chemicals, needles, and sharps, and radiation (from x-ray / fluoroscopy and similar medical equipment).
  • When working in a home office environment, a dedicated office with minimal distractions which assures maximum privacy of computer screens to protect confidential and sensitive information is required; highspeed internet connectivity is required to work effectively.
• Travel (Distributed Workforce) – Approximately 10% of time will be spent traveling for team meetings, conferences, or meetings.
• Physical Demand – While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time. Some of the time standing will include wearing radiation safety equipment (lead aprons, thyroid shield, radiation badge, etc.). Physical effort required by handling objects of up to 25 pounds frequently. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus in relation to travel and operating a personal computer. 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.