Design Engineer 1

MiRus®; Montreal (administrative region); On-site; CAD 97,000 - 118,000; Full time

Benefits offered by this job

401(k)

Dental insurance

Vision insurance

Disability insurance

Health insurance

Life insurance

Paid time off

Relocation assistance

Job summary

MiRus is seeking a Product Development Engineer I to support the design and development of medical devices. You will work within the R&D team to take products from concept through production and regulatory approval, interfacing with engineering, marketing and manufacturing, as well as customers.

Responsibilities include CAD development, GD&T, analyses, and creation of test plans for feasibility and design validation/verification. ISO13485 and FDA guidelines apply.

Qualifications

• BS in Mechanical Engineering or Bio-engineering or equivalent required.
• 1 year of Product Development experience preferred in medical devices.
• Experience with ISO13485 design control is a plus.

Responsibilities

• Provide engineering support for projects as required including CAD model creation and refinement.
• Create engineering prints with tolerances (GD&T) and perform analyses (FEA, tolerance studies, FMEA).
• Conceptualize, design and develop implants and instrumentation; review competitive products.
• Develop preclinical testing plans for feasibility and V&V activities; document results.
• Ensure compliance with ISO and FDA QMS requirements and manage project files.

Skills

CAD

Communication

Time management

Problem solving

Team collaboration

Education

BS in Mechanical Engineering or Bio-engineering

Tools

SolidWorks

Job description

Posted 5 years ago

MiRus team led by Jay S. Yadav, MD, an internationally recognized interventional cardiologist and founder of a number of successful companies has pioneered new treatments for stroke and heart failure patients. Inspired by the pioneering material science of NASA for rocket engines, MiRus has created Rhenium based medical alloys that are transforming medicine by making surgeries less invasive and implants safer and more durable. The team behind MiRus has a history of creating cutting edge technology and leverages its expertise in creating innovative technology for spine, orthopaedics, and structural heart disease. We are creating innovative medical device and procedural solutions for the treatment of spine, orthopaedic and structural heart disease for patients suffering from debilitating diseases. To accomplish this goal, we collaborate with the world’s best surgeons and doctors, hire gifted people and provide them with ample resources to solve complex problems. We provide a safe, inclusive and merit-based workplace and expect our personnel to adhere to the highest ethical standards.

Essential Job Functions

The Product Development Engineer I, is responsible for the support, implementation, execution, control and completion of specific project activities ensuring consistency with company strategy, commitments, and goals. This team member is a part of MiRus' R&D Team which focusses on design and development engineering of medical devices using a streamlined, proven process for taking a product from initial concept to production and regulatory approval. This team member reports to the management of engineering and collaborates with other MiRus staff such as Product Development Engineers, Marketing and Manufacturing Staff, as well as with Customers.

Responsibilities

• Provide Engineering support for projects as required including:
• Create and refine CAD models
• Create detailed engineering prints including tolerances (GD&T)
• Engineering Analysis including calculations, FEA, tolerance studies, FMEA
• Conceptualization, design and development of new products such as implants and instrumentation
• Performing competitive product reviews and analyses
• Performing intellectual property reviews and analyses
• Developing preclinical testing plans and protocols for feasibility and design V&V activities
• Creating design inputs from customer requirements
• Create and execute project work plans and revise as appropriate to meet changing needs and requirements
• Support internal and external activities required to carry out projects
• Administer the document (electronic and paper) control aspects of Mirus R&D, including Engineering project files, Design History Files, and Device Master Records
• Must comply with applicable ISO and FDA regulations as stated in Quality Management System (QMS).
• Other duties as assigned

Qualifications

Education and Certification

• BS in Mechanical Engineering or Bio-engineering or equivalent required.

Experience

• 1 year of Product Development experience preferred.
• Experience to be in product design, preferably in medical devices and orthopaedics within an ISO13485 compliant design control system
• FDA and ISO systems for medical devices experience preferred

Knowledge, Skills and Abilities

• Ability to use the computer and/or CAD (Solid Works preferred)
• Utilizing either written or oral format, ability to effectively communicate critical design/project information to other team members, management & customers
• Ability to prioritize and manage multiple tasks
• Ability to conduct research on project-related issues and products
• Must be able to learn, understand and apply new technologies
• Knowledge of and ability to apply organizational skills as well as good time management
• Ability to apply logic and reasoning to help solve complex problems in creative and effective ways
• Work well under direction, with limited supervision and make high-quality and communicate challenges faced clearly

Language and Mathematical Skills

Language Skills: Ability to read, analyse and interpret common scientific and technical journals and legal documents. Ability to present to team and management.

Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis.

Physical Demands & Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, and talk or hear. The employee frequently uses hands and arms to finger, feel, reach or handle. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

Disclaimer

This Job Description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible responsibilities, tasks, and duties, and does not limit the assignment of additional duties for this position.

Benefits

• MiRus offers competitive compensation, options, full benefits, and relocation assistance.
• 401(k)
• Dental insurance
• Vision insurance
• Disability insurance
• Employee assistance program
• Flexible spending account or Health Savings Account
• Health insurance
• Life insurance
• Paid time off

Schedule

• Monday to Friday (8am - 5pm, but can be flexible)

Work Location

• One location (Marietta, GA)