R&D Design Engineer II
$71k - $95kApplied Medical
Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
Position Description
- Design and develop medical device components, assemblies, and fixtures using Computer-Aided Design (CAD) tools such as SolidWorks.
- Build and test prototypes to evaluate design feasibility, functionality, and manufacturability.
- Collaborate with cross-functional teams, including manufacturing, clinical development, and quality engineering, to ensure product design alignment across the full development cycle.
- Prepare detailed design documentation, including engineering drawings, models, and design review materials.
- Apply Geometric Dimensioning and Tolerancing (GD&T) to ensure precision in component and assembly designs.
- Conduct product verification and validation testing, documenting results and implementing design improvements.
- Conduct design analyses and participate in risk assessments to ensure compliance with medical device regulations and standards.
- Participate in process development to ensure seamless transition from design to production.
- Add about machine/equipment troubleshooting and documentation
- Delivering high-quality, manufacturable designs that meet engineering, clinical, and regulatory standards.
- Building functional prototypes that demonstrate design intent and support clinical evaluation.
- Collaborating effectively with cross-functional partners to ensure smooth product transitions.
- Applying analytical and problem-solving skills to resolve technical challenges during design and testing.
- Contributing to continuous improvement and innovation across the medical device development process.
- Bachelor's degree in mechanical, industrial, or manufacturing engineering, or equivalent.
- Up to three years of relevant engineering experience in product design, prototyping, or process development.
- Proficiency with CAD software such as SolidWorks for 2D and 3D modeling.
- Understanding of GD&T and engineering documentation standards.
- Experience creating and testing prototypes using hands-on tools and fabrication techniques.
- Strong analytical and technical problem-solving skills.
- Excellent communication, organization, and documentation abilities.
- Ability to work collaboratively in cross-functional teams and operate independently when required.
- Experience in medical device design, manufacturing, or regulated industry environments.
- Knowledge of surgical procedures, minimally invasive technologies, or clinical applications.
- Familiarity with FDA and ISO 13485 quality systems and design controls.
- Exposure to Failure Mode and Effects Analysis (FMEA) and Test Method Validation (TMV).
- Experience with Finite Element Analysis (FEA), tolerance analysis, or statistical analysis using Minitab.
- Working knowledge of Product Lifecycle Management (PLM) systems such as NetWeaver.
- Competitive compensation range: $71000 - $95000 / year (California).
- Comprehensive benefits package.
- Training and mentorship opportunities.
- On-campus wellness activities.
- Education reimbursement program.
- 401(k) program with discretionary employer match.
- Generous vacation accrual and paid holiday schedule.
Please note that the compensation range may be based on factors such as relevant education, qualifications, experience. The compensation range may be adjusted in the future, and special discretionary bonus or incentive compensation plans may apply. Our total reward package reflects our commitment to team member growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life. Equal Opportunity Employer Applied Medical is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other basis protected by federal, state or local laws in the locations where Applied Medical operates.
$75k - $95k
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