Sr. Product Development Engineer

Freudenberg Medical LLC; Carpinteria (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Freudenberg Medical LLC is seeking a senior engineer to lead cross‑functional medical device development programs and drive design controls and regulatory compliance. You will translate customer needs into specs, guide risk management, and collaborate with suppliers to bring devices to market.

The role emphasizes prototyping, verification testing, and ongoing process improvements within a fast-paced team environment with opportunities for mentorship and IP contributions.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Biomedical, etc.) or related field.
• 8+ years engineering experience in medical device or related industry.
• Experience with GMP principles and country-specific regulatory requirements.
• Knowledge of global regulatory requirements including risk management.
• Experience supporting customer/clinical studies and data collection.
• Proficient in rapid prototyping and creating design documentation.

Responsibilities

• Lead and manage multiple cross-functional medical device development projects with on-time deliverables.
• Prepare and lead design documentation and design history files per ISO/regulatory standards.
• Translate customer needs into design requirements and lead risk management activities.
• Develop prototypes, drawings, select materials, and collaborate with suppliers.
• Lead design verification activities and testing with documentation of results.
• Collaborate with customers, marketing, regulatory, and manufacturing teams.
• Provide engineering support for design/process changes and launches; drive continuous improvement.
• Support audits and compliance as subject matter expert.
• Contribute to IP discussions and invention disclosures.
• Mentor junior staff and support business development opportunities.

Skills

Project management

Cross-functional leadership

Design for manufacturability

Prototyping

Technical communication

Education

Bachelor's degree in Engineering (Mechanical, Biomedical, etc.)

Tools

MS Project

3D modeling

Technical drawings

Job description

Working at Freudenberg: We will wow your world!

Responsibilities

• Lead and manage multiple cross‑functional product development projects, ensuring on‑time completion of deliverables while providing technical leadership throughout the product lifecycle.


• Prepare and lead design/development documentation, such as design input/output records, protocols, reports, and design history files in accordance with ISO, applicable regulatory and company standards.


• Translate customer requirements, user needs and/or other inputs into clear design requirements, specifications, and design input documentation (as applicable); participate in and lead risk management activities, design/project reviews, and verification testing to ensure product safety and efficacy; apply engineering analysis, design principles, and risk management tools to drive sound design decisions.


• Develop and evaluate prototypes, generate drawings/specifications, select appropriate materials, develop processes, and collaborate with suppliers to support device design, process development and manufacturing in compliance with regulatory and quality requirements.


• Lead process characterization and design verification activities, including test method development, fixture design, execution of testing, and documentation of results.


• Partner with customers/clinicians, marketing, regulatory, quality, NPI/manufacturing, and external experts to develop novel medical devices, assess new technologies/processes, and ensure clinical relevance and manufacturability of designs.


• Provide engineering support for design/process changes and product launches, resolving technical challenges and driving continuous improvement initiatives.


• Support audits and compliance activities as a subject matter expert.


• Participate in intellectual property activities by contributing to invention disclosures, patent strategy discussions, and design differentiation.


• May be asked to provide input to performance review Formally trains and mentors' junior staff, or acts as a resource for colleagues with less experience Support business development activities and opportunities.


• Strong interpersonal and communication skills dealing with internal and external customers.

Qualifications

• Bachelor's/University degree in Engineering (Mechanical, Biomedical, etc.), or related science/technical field.


• 8+ years' experience of engineering in medical device or related industry experience.


• Extensive knowledge and understanding medical device standards and regulations


• Extensive knowledge of GMP principles and their application in medical device manufacturing, including country -specific regulatory requirements


• Knowledge of global regulatory requirements including risk management efforts and thorough risk assessments and mitigation strategies.


• Experience supporting customer/clinical studies, collecting data, and collaborating with customer/clinicians to ensure compliance with study protocols.


• Strong familiarity with rapid prototyping techniques.


• Experience with 3D solid modeling and technical drawings of medical devices desirable.


• Execution of Design for Manufacturability (DFM) principles and process characterization activities to design and develop products that are manufacturable and cost effective.


• Strong experience with Project Management (including organizing and facilitating meetings, project planning, balancing multiple projects, and budgeting) and Project management tools (e.g. MS Project).


• Knowledge of biocompatibility requirements and expertise in selecting appropriate materials for medical device applications and incorporating human factors engineering principles to optimize medical device usability and user experience.


• Knowledge of IP laws and practices, including patent applications and protection of proprietary technologies.


• Proven ability to lead cross‑functional teams to achieve project objectives.


• Leadership skills in establishing and managing comprehensive design control processes, ensuring adherence throughout the product lifecycle.


• Ability to work independently and also lead small teams in a fast‑paced, results‑oriented environment.


• Ability to generate complex prototypes using various materials and techniques to test and validate product designs.


• Ability to effectively communicate complex technical issues and solutions to non‑technical internal and/or external customers in both oral and written methods.


• Ability to create and maintain technical documentation, such as design specifications and test reports.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Freudenberg Medical LLC Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications. Working at Freudenberg: \"We will wow your world!\" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer your 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.