Description
Reports To: Director, Design ServicesSUMMARY:
The Research and Development Engineer is responsible for providing engineering knowledge, skill, and ability to handle such tasks as: project management, engineering design, prototyping development, gathering of pertinent back round information, and leading project and design teams from conception through commercial launch of medical devices. Additionally, the Research and Development Engineer will be responsible for managing project costs, issuing quotes to customers, procuring material quotes, interacting with customers while ensuring full compliance to FDA QSR (21 CFR 820), and applicable ISO 13485 requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Include the following. Other duties may be assigned.
- Will be responsible for establishing product requirements, concept prototyping, design and development (including verification and validation), risk/failure mode assessment, performance and safety testing.
- Coordinate time and activities of others and/or serve as a project leader for cross-functional programs.
- Maintains detailed documentation throughout all phases of research and development.
- Reviews or coordinates outside vendor activities to support development.
- Manages or develops technical solutions to design problems with vendors and in-house resources through design reviews, design audits, and prototype analysis.
- Interface with customers and internal departments articulating team activities and progress.
- Work closely with pilot manufacturing engineering to verify scalability of the product.
SUPERVISORY RESPONSIBILITIES:
May directly supervise one or more technicians.
COMPETENCIES: To perform this job successfully, and individual should demonstrate the following competencies:
- Analytical - Collects and researches data; Uses intuition and experience to complement data.
- Design - Generates creative solutions; Demonstrates attention to detail.
- Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
- Project Management - Communicates changes and progress.
- Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
- Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to other's ideas and tries new things.
- Oral and Written Communication - Listens and gets clarification. Writes clearly and informatively; Able to read and interpret written information.
- Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others view's; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
- Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decision; Includes appropriate people in decision-making process; Makes timely decisions.
- Motivation and Planning/Organizing - Measures self against standard of excellence. Uses time efficiently.
- Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
- Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
- Quantity - Meets productivity standards; Completes work in a timely manner; Strives to increase productivity; Works quickly.
- Safety and Security - Observes all safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
- Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent changes, delays, or unexpected events.
- Attendance/Punctuality - Is consistently at work on time; Arrives at meetings and appointments on time.
- Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
- Initiative - Volunteers readily; Undertakes self-development activities; Asks for and offers help when needed.
- Innovation - Displays original thinking and creativity; Meets challenges with Resourcefulness; Generates suggestions for improving work.
- Excellent computer skills including Microsoft office (Word, Excel, PowerPoint) statistical software, Solid works or AutoCAD software.
- Highly motivated with a sense of urgency in resolving quality issues relating to customer requirements and demands.
- Possess strong verbal and written communication skills.
- Excellent time management skills. Demonstrated ability to complete timeline commitments.
- Able to adapt to changing priorities and manage multiple initiatives concurrently.
Ability to work with people at all organizational levels. - Demonstrated ability to lead problem solving teams.
- Proven track record for quality improvement initiatives.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to define problems, collects data, established fact s, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram from the deal with several abstract and concrete variables.
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 essential functions.
EDUCATION AND/OR EXPERIENCE:
B.S. in Mechanical Engineering or Bachelor's Degree plus a minimum of seven (7) years experience in a related regulated medical device environment. Or a Master's Degree with 0-2 years of related work experience, or an equivalent combination of education and work experience.
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