Senior Staff Engineer - Mechanical (Computer-Aided Engineering)

Who we want:

Analytical and innovative: Individuals who are passionate about simulation-driven new product development and can push the boundaries of physics-based analytical technologies and predictive analytics.

Problem-solving prowess: People who not only address immediate issues but also excel at identifying root causes, evaluating optimal solutions, and proposing comprehensive upgrades to prevent future problems.

Dedicated achievers: Those who are unwavering in their commitment to quality, thrive in a fast-paced environment, and are determined to ensure that projects are completed to meet regulatory and quality standards.

Curious learners: Engineers who actively seek out the latest research and information to continuously improve their computer-aided engineering skills.

Goal-oriented developers: Individuals who prioritize customer and system requirements, focusing on delivering safe and robust solutions.

Collaborative partners: People who excel at building and leveraging cross-functional relationships, using them to gather ideas, share information, discuss use cases, and analyze industry trends to develop best practices.

What you will do:

Technical Responsibilities:

• Lead the integration of advanced simulation tools, including finite element analysis (FEA), and methodologies into the product development process, enabling data-driven design decisions and reducing reliance on physical prototypes.
• Develop and validate complex simulation models, ensuring accuracy through correlation with experimental test data.
• Research and implement innovative simulation techniques to address complex challenges in medical device design and performance.
• Partner with cross-functional teams to align simulation insights with broader project objectives, ensuring regulatory and quality compliance.
• Establish and maintain best practices, standards, and documentation for simulation workflows to enhance consistency and efficiency.
• Lead research, design, development, modification and evaluation of modules, assemblies, or subsystems.
• Apply and mentor others on advanced engineering theories, principles, and concepts.
• Conduct, design, and select advanced prototyping and testing.
• Lead and guide in correction of complex product design issues.
• Conduct technology exploration and influence application in the business.
• Develop invention disclosures, patents or trade secrets.

Business Responsibilities:

• Apply strong understanding of clinical procedures to enhance product development.
• Contribute and execute customer facing activities like voice of customer and customer centric design in partnership with internal and external stakeholders.
• Demonstrate financial acumen.

Med Device Compliance:

• Mentor others as a business unit expert on the usage of industry standards, including design requirements and test strategies per applicable regulations.
• Lead others to create and refine engineering documentation, such as the Design History file and create more progressive technical content. 
• Contribute to R&D procedures and development of industry standards working closely with cross-functional business units.

General Responsibilities:

• Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.
• Identify and lead the creation of or improvements to procedures, policies, processes, systems, and technology required.
• Develop, Research, Prototype, leveraging multiple methodologies for evaluation.
• Contribute to complex product development through release and lead one technical area of expertise.
• Hold self and others accountable to deliver high quality results with passion, energy and drive to meet business priorities.
• Mentor, develop and inspire others in current and future roles.
• Collaborate and influence others on cross functional teams advancing partnerships to achieve business objectives

Minimum Qualifications (Required):
• Bachelor of Science in Engineering, Mechanical Engineering or BioMedical & 6+ years of work experience

Preferred Qualifications (Strongly desired):

Technical Skills:

• Experience in developing and optimizing complex designs for mechanical / electro-mechanical assemblies incorporating DFM principles.
• Experience in creating engineering drawings, models, applying GD&T and CAE tools to optimize the design.
• In-depth knowledge of materials, manufacturing and processing methods and technologies to support complex product development.
• Ability to communicate complex plans and technical information to team members.

Preferred Skills / Engineering tools:

• Proficiency in industry-standard simulation software, such as Ansys Mechanical, LS-Dyna, or Nastran.
• Significant experience with advanced finite element analysis methods, including static, dynamic, implicit, and explicit simulations.
• Familiarity with multidisciplinary simulation workflows, such as structural, thermal, fluid dynamics (CFD), and electromagnetic analyses.
• Knowledge of validation and verification processes, including standards like ASME V&V 40.
• Proficiency in scripting and automation using tools such as Python or MATLAB to enhance simulation efficiency.
• Experience with parametric modelling (Creo) and multi-objective optimization techniques.
• Expertise in the properties and applications of materials such as metals, polymers, and elastomers, with the ability to optimize designs based on material selection and performance characteristics.