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KLS Martin Group · 1 month ago

PRINCIPAL R&D ENGINEER (31271)

Jacksonville, FL

Full-time

Onsite

Senior Level, Lead/Staff

7+ years exp

KLS Martin Group is a worldwide leader in creating surgical solutions for the craniomaxillofacial and cardiothoracic fields. The Principal R&D Engineer will perform high-level engineering work, responsible for developing new products from concept to commercialization, ensuring compliance with FDA regulations, and providing leadership and mentorship to junior team members.

Information TechnologyMedical

H1B Sponsor Likely

Responsibilities

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

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

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

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

Identify, assess, and mitigate risks associated with product development, ensuring that risk management processes comply with FDA expectations and international standards (ISO 14971)

Work closely with cross-functional teams, including quality assurance, manufacturing, and regulatory affairs, to ensure seamless product development and regulatory compliance

Oversee and conduct testing for verification and validation activities to demonstrate product safety, performance, and effectiveness, in accordance with FDA regulations

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

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

Drive continuous improvement initiatives in R&D processes and practices to enhance efficiency and effectiveness while maintaining compliance with FDA requirements

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

Qualification

FDA regulationsISO 13485ISO 149713D CAD modelingMechanical testingDesign controlRisk managementProblem solvingCommunication skillsInterpersonal skillsCritical thinkingAdaptability

Required

BS in Engineering (Mechanical, Bioengineering, Biomedical) or comparable technical/medical field required

Thorough understanding of FDA regulations, including 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 807 (Establishment Registration and Device Listing)

Proficiency in risk management, design control, mechanical testing and product development processes

Strong problem-solving skills and the ability to work effectively in cross-functional teams

7-12 years engineering experience in design and development, medical device preferred

Prior experience with 3D CAD modeling software such as Solidworks, Freeform

GD&T experience applied to engineering drawing

Proficient user of Microsoft Office applications

Ability to learn new software quickly

Ability to retrieve and interpret documentation

Able to work independently under minimal supervision and accomplish goals

Able to efficiently communicate and collaborate with teams

Strong interpersonal skills with the ability to effectively communicate at all levels internally, as well as externally

Problem solving & decision making

Strong communication skills, both written and orally

Critical thinking

Adaptability & flexibility

Typing/computer keyboard

Utilize computer software (specified above)

Retrieve and compile information

Maintain records/logs

Verify data and information

Organize and prioritize information/tasks

Operate office equipment

Advanced mathematical concepts (fractions, decimals, ratios, percentages, graphs)

Verbal communication

Written communication

Public speaking/group presentations

Research, analyze and interpret information

Investigate, evaluate, recommend action

Basic mathematical concepts (e.g. add, subtract)

Abstract mathematical concepts (interpolation, inference, frequency, reliability, formulas, equations, statistics)

Sitting for extended periods

Extended periods viewing computer screen

Walking

Reading

Speaking

Hear/Listen

Maintain regular, punctual attendance

Lifting/carrying up to 20 pounds various items

Repetitive Motions

Pushing/Pulling

Bending/Stooping

Reaching/Grasping

Writing

Preferred

Master's degree in engineering (Mechanical, Bioengineering, Biomedical) or comparable technical/medical field strongly preferred

Experience with ISO 13485 and ISO 14971 standards is highly desirable

Prior Windchill experience would be a plus

Benefits

Competitive benefits package

Paid parental leave

In-house training and professional development opportunities

Culture of creativity and innovation

Company

KLS Martin Group

KLS Martin Group is a globally leading supplier of medical technology solutions for almost all surgical fields.

Founded in 1896

Jacksonville, Florida, USA

1001-5000 employees

https://www.klsmartin.com/de/

H1B Sponsorship

KLS Martin Group has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2020 (2)