Sr R/D Engineer - Exempt

Lancesoft; Irvine (CA); On-site; USD 120,000 - 155,000; Full time

Job summary

Lancesoft in Irvine, CA, seeks a Senior R&D Engineer to contribute to Neurovascular (NV) medical devices within the Neuroscience Portfolio. You will ensure compliance with design control, risk management, and regulatory requirements while delivering technical leadership on released products.

Join a cross-functional team and mentor colleagues, author and review engineering docs, lead investigations into nonconformances, and drive continuous improvements in product quality and process performance.

Qualifications

• Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related engineering discipline. Master’s degree preferred but not required.
• 5 years of relevant engineering experience, preferably within the medical device industry.

Responsibilities

• Evaluate and implement design, material, supplier, manufacturing, and labeling changes for released products while ensuring compliance with design control, risk management, and regulatory requirements.
• Author, review, and approve engineering documentation including design specifications, risk analyses, test methods, protocols, reports, engineering change orders, and technical assessments.
• Provide technical leadership for commercialized products, including design improvements, obsolescence mitigation, cost-reduction initiatives, and supply continuity projects.
• Lead investigations and engineering rationale related to product nonconformances, complaints, CAPAs, field issues, manufacturing issues, and supplier quality concerns using structured problem-solving methodologies.
• Create protocols, perform data analysis, and author reports to demonstrate that product and process changes meet design intent and regulatory requirements.
• Collaborate with Manufacturing, Quality, Regulatory Affairs, Supplier Quality, Marketing, Clinical, and Operations teams to evaluate product performance and implement effective solutions.
• Assess supplier changes, manufacturing process changes, equipment qualifications, and material modifications to ensure continued product quality and performance.

Skills

Technical leadership

Cross-functional collaboration

Engineering documentation

Problem solving

Regulatory awareness

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Materials Science

Master's degree preferred

PhD (optional)

Tools

Regulatory practices

Job description

HM's Top Needs: Sustaining/Released product engineering experience Technical Investigation and problem solving Engineering documentation and cross-functional execution Education Required: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related engineering discipline. Master’s degree preferred but not required. Years’Experience Required: 5 years of relevant engineering experience, preferably within the medical device industry Will the contractor be working 40 hours a week? If not, weekly estimate? Yes 40 hours a week Work Location: UCI, 5290 California Ave Irvine site, with potential to be in Toledo mfg site when needed (9775 Toledo Way Irvine) Does this person need to be on site? If so, full time or part time? Yes full time Careers that Change Lives A career at *** is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. The Neuroscience Portfolio develops life-restoring therapies and healthcare solutions that span the care continuum;integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes. Neurovascular (NV) Business Unit offers an integrated portfolio of devices and therapies for the treatment of stroke-related diseases.

A Day in the Life The Senior R&D Engineer is a technical contributor to the Research & Engineering team. This role is responsible for ensuring that NV medical devices comply with corresponding requirements set forth by local procedures, regulatory authorities, and notified bodies. This role will provide technical leadership, deep subject matter expertise, technical/project oversight, and team member training/coaching.

Essential Functions:

• Evaluate and implement design, material, supplier, manufacturing, and labeling changes for released products while ensuring compliance with design control, risk management, and regulatory requirements.
• Author, review, and approve engineering documentation including design specifications, risk analyses, test methods, protocols, reports, engineering change orders, and technical assessments.
• Provide technical leadership for commercialized products, including design improvements, obsolescence mitigation, cost-reduction initiatives, and supply continuity projects.
• Lead investigations and engineering rationale related to product nonconformances, complaints, CAPAs, field issues, manufacturing issues, and supplier quality concerns using structured problem-solving methodologies.
• Create protocols, perform data analysis, and author reports to demonstrate that product and process changes meet design intent and regulatory requirements.
• Collaborate with Manufacturing, Quality, Regulatory Affairs, Supplier Quality, Marketing, Clinical, and Operations teams to evaluate product performance and implement effective solutions.
• Assess supplier changes, manufacturing process changes, equipment qualifications, and material modifications to ensure continued product quality and performance.

Technical Specialist Career Stream:

An individual contributor with responsibility in our technical functions to sustain or advance existing technology. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems or initiatives related to existing or new technologies/therapies, while adhering to policies, using specialized knowledge and skills.

Differentiating Factors

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower-level specialists;may manage projects/processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objectives, and influence decision-making.

Leadership and Talent Management: May provide guidance, coaching, and training to other employees within the job area. May manage projects, requiring delegation of work and review of others'work product.

Required Knowledge and Experience:

Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

Location:

Join us in Irvine, CA, a vibrant city known for its innovation, quality of life, and proximity to Southern California's beautiful beaches and cultural attractions. Work in a dynamic environment where your contributions make a difference.