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Job Summary
The Principal R&D Engineer will perform high level engineering work requiring recognized expertise. This role is responsible for developing new products from concept to commercialization. This includes research, planning, idea creation and realization, concept development, specification generation, maintenance of existing product designs, testing for verification and validations, as well as effective communication with team members, management, and customers. As project responsibilities increase, the R&D engineer will be expected to provide additional leadership and technical mentoring along with more cross-functional group interaction internally and externally. Participates in product development teams and is responsible for assigned engineering deliverables
Essential Functions, Duties, and Responsibilities
Product Development: Lead and actively participate in the design and development of new medical devices with significant scope or degree of difficulty, ensuring that they meet the highest standards of quality, safety, and efficacy. Perform research and testing on product concepts, new, and existing products. Conduct material, design and process changes to existing products by following design control processes and analyses of defects. Identify areas to streamline or improve cycle time and quality. Performs engineering activities and provides expertise to guide technical project decisions. Conducts technical design reviews as needed to support new product development.
FDA Compliance: Stay up-to-date with the latest FDA regulations, guidance documents, and industry standards related to medical devices. Apply this knowledge to develop and maintain compliant design control processes and documentation.
Regulatory Strategy: Collaborate with regulatory affairs teams to create and execute regulatory strategies for new product submissions, including 510(k) premarket notifications, PMA (Pre-market Approval) applications, and other regulatory submissions.
Design Control: Establish and manage design control procedures, including risk management, design verification and validation, design transfer, and change control processes in alignment with FDA requirements and ISO standards.
Risk Management: Identify, assess, and mitigate risks associated with product development, ensuring that risk management processes comply with FDA expectations and international standards (ISO 14971).
Cross-functional Collaboration: Work closely with cross-functional teams, including quality assurance, manufacturing, and regulatory affairs, to ensure seamless product development and regulatory compliance.
Testing: Oversee and conduct testing for verification and validation activities to demonstrate product safety, performance, and effectiveness, in accordance with FDA regulations.
Documentation and Reporting: Prepare and maintain detailed documentation of all R&D activities, including design history files, technical files, and regulatory submissions. Ensure timely and accurate reporting to regulatory authorities.
Problem Solving: Address technical challenges and issues that arise during product development, providing innovative solutions while maintaining compliance. Reviews and guides the resolution of technical issues as needed and ensures that technical work meets requirements and specifications.
Continuous Improvement: Drive continuous improvement initiatives in R&D processes and practices to enhance efficiency and effectiveness while maintaining compliance with FDA requirements.
Training and Mentorship: Provide guidance and mentorship to junior engineers and team members on FDA regulations and best practices for medical device development. Plans and assigns work / project tasks / responsibilities to personnel (typically technicians and engineers assigned to the specific project). Generally has no direct subordinates; but provides functional supervision and mentorship to project team members for the duration of project assignment and provides feedback to functional managers regarding performance of junior team members
Educational and Experience Requirements
Knowledge, Skills, and Abilities
Skill Requirements
Physical Requirements
Hazards
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
KLS Martin is a drug-free employer
Other
Medical Technology
$139k-160k (estimate)
01/11/2024
06/02/2024
klsmartin.com
MUHLHEIM AN DER DONAU, BADEN-WURTTEMBERG
500 - 1,000
1896
KARL LEIBINGER
$200M - $500M
Medical Technology
The job skills required for PRINCIPAL R&D ENGINEER include Planning, Problem Solving, Written Communication, Communication Skills, Flexibility, Initiative, etc. Having related job skills and expertise will give you an advantage when applying to be a PRINCIPAL R&D ENGINEER. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by PRINCIPAL R&D ENGINEER. Select any job title you are interested in and start to search job requirements.
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