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Freudenberg Medical · 1 day ago

Sr. Product Development Engineer

Carpinteria, CA

Full-time

Onsite

Senior Level, Lead/Staff

$120K/yr - $150K/yr

8+ years exp

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions for medical device and pharmaceutical companies. The Sr. Product Development Engineer will lead and manage multiple cross-functional product development projects, ensuring on-time completion of deliverables while providing technical leadership throughout the product lifecycle.

ManufacturingMedical Device

No H1B

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

Qualification

Medical device engineeringDesign for manufacturabilityProject managementGMP principlesRapid prototyping3D solid modelingLeadership skillsInterpersonal skillsTechnical documentationCommunication skills

Required

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

Benefits

401K Match: Save for retirement with the company's help.

Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.

Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.

Performance Related Bonus: When you have an impact, you can reap the rewards.

Personal Development: We offer a variety of trainings to ensure you can develop in your career.

We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time-off.