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Staff Mechanical Design Engineer

3 months ago

Denver, United States K1C Consulting LLC Full time

Company Overview

K1C Consulting is a dynamic engineering and product design partner, propelling groundbreaking ideas from concept to commercialization. We specialize in tackling complex design challenges across industries, including medical devices, sports technology, and aerospace.

Our team delivers comprehensive solutions, from initial concept development and rigorous testing to prototype creation and seamless product launch. Our clients are pioneering startup and established industry leaders who engage us to provide the strategic guidance and technical prowess to turn their visions into reality.


Position Overview

This role demands a highly skilled mechanical engineer to drive the design, development, and optimization of new medical device technologies. The successful candidate will be instrumental in both new product innovation and the enhancement of existing products. This position requires a hands-on approach to problem-solving, a keen eye for identifying cost-saving opportunities, and a commitment to delivering exceptional client experiences. You will play a pivotal role in product design, scaling, improving product reliability, and ensuring the long-term success of numerous new product lines for our clients ranging from small startups to fortune 500 companies.


Essential Job Functions

·       Navigate complex and ambiguous technical challenges with timely decision-making and appropriate prioritization.

·       Rapidly iterate product designs through prototyping, testing, and analysis using engineering tools and techniques, including computer simulation and physical modeling.

·       Work within and lead multidisciplinary teams to design, develop, and document mechanical components and assemblies for new product designs.

·       Define functional requirements based on user and product-level requirements and international standards.

·       Maintain Design History Files according to regulatory and client guidelines.

·       Lead design risk management activities such as Failure Mode and Effects Analysis (FMEA) and implement effective mitigation strategies.

·       Develop and maintain product specifications, prioritizing critical functions, safety, manufacturability, and cost.

·       Generate engineering drawings in compliance with GD&T and client standards.

·       Support and participate in clinical and human factors evaluations to optimize user experience.

·       Collaborate with clients, manufacturing partners, and quality to ensure smooth transition production.

·       Mentor and develop junior engineers.

·       Contribute to team and organizational goal setting.

·       Champion best practices in mechanical design.


Required Skills and Experience

·       Minimum 12 years of hardware product design experience in medical device or other regulated industry.

·       BS or higher degree in Mechanical or Biomechanical Engineering is required. Other engineering discipline may be acceptable with appropriate mechanical experience.

·       Led a full product development lifecycle including ideation, design, debug, verification, qualification, transfer to manufacturing, and sustaining.

·       Demonstrated enthusiasm and ability to learn and quickly analyze tough technical problems using design thinking, exceptional mechanical intuition, and persistence to pinpoint root cause of problems.

·       Demonstrated ability to think at a systems level, interface between multiple stake holders, and negotiate conflicting requirements.

·       Understanding concepts of design input, design output, requirement traceability, and FMEA risk analysis.

·       Mechanical design and analysis skills, including statics, dynamics, and strength of materials, including stress analysis, fatigue, and thermal.

·       Proficiency with CAD (SolidWorks highly preferred): designing parts with complex geometry, creating assemblies, creating detailed manufacturing drawings, and examining designs with Finite Element Analysis (FEA).

·       Fluency in ASME Y14.5 GD&T and tolerance stack analysis.

·       Demonstrated knowledge of materials (metal alloys, plastics, elastomers) and material properties. Ability to apply knowledge of engineering materials and component selection criteria to product designs through exceptional concept development, design analysis, hands-on prototyping, and reliability testing skills.

·       Design for Excellence (DFX) for various manufacturing processes (including injection molding, thermoset molding, machining, vacuum thermoforming, pad printing, laser marking, etc.) for high-volume manufacturing.

·       Proficiency at failure analysis, including root cause analysis techniques (e.g., fishbone, 5 Whys, etc.)

·       Comfortable operating in labs (wet, cadaver & mechanical), measurement, and test environments.

·       Demonstrated ability to create and execute an engineering test plan, and proficiency at writing engineering test reports.

·       Ability to communicate effectively (written, oral) across functions, including presenting to a technical audience.

·       Working knowledge of ISO requirements and GMP guidelines for medical device design control including FDA QSR 21 CFR Part 820, ISO 13485, IEC 60601, and other related external standards.


Required Soft Skills

·       Can-Do attitude, and willingness to get their hands dirty.

·       A learn it all mentality.

·       Detail-oriented personality with solid documentation and reporting skills.

·       Passionate about mechanical design.

·       Has a physics-based understanding of a variety of process technologies and the potential applications of many.

·       Supportive, patient, and willing to mentor clients.

·       Tolerance for the realities of early product development: you'll generate and test lots of ideas quickly, throw out most of your work, and experience permanent ambiguity around what projects you'll be working on next.

 

Compensation and Benefits

·       Compensation: It is not typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications.  The target salary ranges are: $130,000 to $180,000

·       Paid time off, paid holidays, and a flexible schedule

·       Health/dental/vision insurance packages

 

Work Authorization

Please note that applicants are responsible for ensuring their eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without need of employer sponsorship) on or before the effective date of employment.


Work Location

Denver, CO with a minimum of 60% onsite with remainder remote. Some onsite client and supplier visits are required.

 

Equal Opportunity Employer

We are an equal opportunity employer and value diversity at our company. Women, BIPOC, people who are differently abled, and members of the LGBTQ+ community are encouraged to apply. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status, and actively seek out and value diverse perspectives.