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Accure Acne, Inc.
Boulder, Colorado, United States (on-site)
23 hours ago
John Deere
Dubuque, Iowa, United States (on-site)
19 days ago
Environmental Law & Policy Center
27 days ago
Accure Acne, Inc.
Boulder, Colorado, United States
(on-site)
23 hours ago
Job Type
Full-Time
Job Duration
Indefinite
Salary
$135,000.00 - $180,000.00
Min Experience
Over 10 Years
Min Education
BA/BS/Undergraduate
Required Travel
10-25%
Salary - Type
Yearly Salary

Description

As the hardware engineering manager, you will lead a dynamic team of experienced medical device design and test engineers in developing new product applications and providing support for existing products.  In this role, you will collaborate closely with the engineering software and clinical teams, as well as the Accure commercial teams, to gain insights into clinical applications, develop product requirements, resolve product issues, and provide engineering support.

Reporting to the Accure Chief Technology Officer, this role requires a roll-up-your-sleeves, do-what-it-takes job approach and a passion for cutting-edge solutions.  This position involves exciting and rewarding work, and a zest for developing cutting-edge solutions that positively impact people is essential for success.

Specific duties and

Key Responsibilities

Specific duties entail, but are not confined to:

·      Lead and manage the hardware engineering team.

·      Drive product development efforts through all phases of design, from feasibility to transfer to manufacturing.

·      Direct and coordinate activities related to the design, development, and implementation of new products, as well as modifications to existing ones.

·      Provide supervision, mentoring, training, and guidance to engineering personnel.

·      Offer expertise and guidance to the team on industry best practices to ensure high-quality deliverables.

·      Manage project timelines and ensure the completion of tasks within set deadlines while reporting progress to senior management.

·      Provide oversight to ensure proper implementation and compliance of design control procedures for the creation and maintenance of FDA, MDR, ISO, and MDSAP with Design History Files (DHF) and quality assurance processes.

·      Guide the team in effective problem-solving, root-cause analysis, and implementation of solutions.

·      Participate in complaint investigations and product failure, providing root cause analysis support as required.

·      Lead or participate in activities related to addressing non-conformances and implementing corrective and preventive actions (CAPA).

·      Support Regulatory Affairs (RA) and Quality Assurance (QA) with changes to standard operating procedures, design history files, and essential requirements to ensure compliance with various auditing bodies for our quality system, including FDA, MDR, ISO, and MDSAP, among others.

·      Collaborate with commercial and field service teams to track and resolve issues.

·      Collaborate closely with contract manufacturing partners to oversee design changes, meet new product requirements, and provide support through the manufacturing process.

·      Work closely with the Advanced Concepts team on R&D for new device technologies and capabilities.

·      Partner with principal investigators on clinical trials and application development, as required.

Travel to clinics, conferences, and other relevant events as required.



Requirements

•    BS in biomedical, mechanical, electrical, or optical engineering or equivalent.
•    Extensive experience in medical device engineering.
•    Minimum of 8 years of engineering experience in complex medical electrical devices design and development.
•    Minimum of 3 years of managerial experience for consideration as a Senior Manager.
•    Preference for familiarity with the medical device electrical safety & EMC requirements (IEC60601-1).
•    Knowledge of design for usability, serviceability, and manufacturability required.
•    Proficiency in quality systems regulations, including FDA QSR, ISO 13485, and MDSAP is required.
•    Exceptional leadership and management skills.
•    Proven ability to collaborate effectively with leadership and cross-functional teams.
•    Outstanding organizational skills with meticulous attention to detail.
•    Excellent communication skills, both verbal and written. 
•    Proficient in problem-solving through critical thinking and root-cause analysis, capable of making confident decisions with minimal direction.
•    Strong ability to prioritize tasks, multitask efficiently, and adapt to changing circumstances.
•    Exhibit high degree of initiative and self-motivation with a strong sense of accountability.
•    Demonstrate professionalism and positivity in interactions with external partners and customers.
•    Comfortable working in clinical environments, including physician offices, clinics, and hospitals.
•    Openness to primarily work from the company office. 
•    Ability to travel up to 15% of the time annually.

Job ID: 72504342

Please refer to the company's website or job descriptions to learn more about them.

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