Product Engineer II (Mid)

Company: Breg, Inc.
Location: Carlsbad
Posted on: February 1, 2025

Job Description:

Job Category: Engineering Design & DevelopmentRequisition Number: PRODU004367Posted: January 14, 2025Employment Type: Full-TimeWork Arrangement: HybridLocationsShowing 1 locationDescriptionAre you looking for an exciting opportunity?We currently have a full-time opening for a Product Engineer II in our Carlsbad location. If you are looking for a fast-paced environment where you can make a difference every day, then this is the opportunity for you!The right person to join our team is...Demonstrates ownership and accountability; the ability to plan, track, and accomplish goals; ability to communicate effectively both written and verbal. S/he will rely on their experience and judgement to make recommendations and/or decisions within the scope of their essential job responsibilities. Demonstrates the ability to mentor and train.This position is responsible for---.As a Product Engineer II in the medical device industry, you will play a vital role in driving the product development process from concept to production for medical device projects. You will collaborate with cross-functional teams to design, develop, and launch innovative products that meet customer needs, align with regulatory requirements, and support our company's strategic objectives. This position requires a results-driven individual with demonstrated technical expertise, excellent problem-solving skills, and a passion for delivering high-quality medical devices.Your day will be very busy--- you will:

• Participate in the development and execution of large-scale medical device product design and development projects, ensuring alignment with customer requirements, regulatory standards, and company objectives. Lead small-scale medical device product design and development projects.
• Collaborate with multidisciplinary teams, including design, manufacturing, quality, regulatory affairs, and marketing to deliver innovative medical devices on time and within budget.
• Develop product specifications, design documentation, risk assessments, and test plans for new medical devices under guidance from senior engineers.
• Perform design validation and verification activities to ensure that medical devices meet performance, reliability, and regulatory requirements, including FDA and ISO standards.
• Identify and resolve technical issues during product development, testing, and production phases while considering patient safety and risk management.
• Participate in design reviews and provide feedback to improve product quality, performance, and compliance with industry-specific regulations.
• Support continuous improvement initiatives by identifying opportunities to optimize processes, reduce costs, and enhance product performance.
• Stay current with industry trends, emerging technologies, and best practices in the medical device field to contribute to the innovation of new products.
• May assist in the mentoring and training of more junior engineers.What your background will be:
  • Bachelor's degree in engineering (Biomedical, Mechanical, Electrical, or related field) from an accredited university is required. A master's degree is a plus.
  • 3+ years of experience in product development within the medical device industry or a related field is required.
  • Understanding of engineering principles, materials, manufacturing processes, and quality control methods specific to the medical device industry is required.
  • Familiarity with regulatory requirements for medical devices, including FDA regulations and ISO standards is required.
  • Proficient in CAD software (e.g., SolidWorks, AutoCAD) and other engineering tools relevant to medical and sports medicine product device development is required.
  • Experience with Oracle is preferred.
  • Proven track record of successful medical device development projects from concept to production is required.
  • Strong problem-solving skills and ability to apply engineering concepts to real-world situations within the medical device context is required.
  • Strong communication skills, both written and verbal, with the ability to effectively communicate complex technical information to various audiences is required.
  • Ability to work both independently and collaboratively in a fast-paced environment is required.What we can offer you...Our insurance benefits are effective the 1st of the month after your hire date.This range reflects the minimum and maximum target range for new hire base salary/pay across all US locations. Actual pay is based on many factors unique to each candidate, including but not limited to geographical location, work experience, skill set, relevant trainings and certifications, and business needs. The base pay range is subject to change and may be modified in the future. This role may also be eligible for bonus.For six consecutive years, Breg was awarded The National Business Research Institute (NBRI) Circle of Excellence Award for employee engagement.If you meet the requirements above and would like to apply for this position, please visit our website at www.breg.com and click on the 'Careers' section.Breg is an Equal Employment Opportunity Employer and dedicated to a diverse workforce and Drug-Free work environment. EOE/Minorities/Females/Vet/Disabled are encouraged to apply.Applicants must be currently authorized to work in the United States on a full-time basis. The Company will not sponsor applicants for work visas for this position.
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Keywords: Breg, Inc., San Bernardino , Product Engineer II (Mid), Engineering , Carlsbad, California