Sr. Product Development Engineer

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.

Job Type & Location

This is a Permanent position based out of Carpinteria, CA.

The pay range for this position is $140000.00 - $186000.00/yr.

9/80 schedule Located in camarillo California in a fast pace environment. Lucix works with some of the top A&D primes in the country 401k and benifits

This is a fully onsite position in Carpinteria,CA.

This position is anticipated to close on May 14, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $140,000 - $186,000