Staff Hardware Engineer

MINIMUM OF 6 YEARS OF RELATED EXPERIENCE IS REQUIRED ABOUT US True Digital Surgery is a World Leader in Computer-Guided Microsurgery.

We combine 3D visualization and guidance software applications focused on improving accuracy, efficiency and outcomes for surgeons and patients.

Our medical imaging and guidance system employs advanced real-time 3D graphic capabilities and proprietary software that is sold to surgeons and hospitals all over the world.

SUMMARY Lead the development of new mechanical designs, drive product improvements, and maintain existing products for our 3D visualization and guidance systems for microsurgery, working closely with electrical, optical, software and system engineers as well as product managers.

The Staff Hardware Engineer will interface with internal and external teams to deliver complex designs such as high-magnification optical cameras, robotic assisted positioning systems, and active / passive thermal management systems.

In addition to design and development, the Staff Hardware Engineer will work with a multidisciplinary marketing and engineering team to turn marketing requirements into actionable engineering requirements.

They will interface with internal teams, e.g.

Software, Quality, Procurement, Production, and external teams, e.g. suppliers, outsourced Industrial Designers.

The successful candidate will also be involved in the transfer of products from development to manufacturing including workflow development, production equipment design and throughput optimization.

The role will also require working with project and system engineers to create schedules, help define budgets and derive system / subsystem requirements.

The Staff Hardware Engineer will also mentor junior staff, providing guidance resulting in the team as a whole generating great designs, with a solid design history trail, design documentation, and verification records.

The candidate will also mentor junior staff regarding “soft” engineering skills, including working with vendors, working with other groups to turn loosely stated marketing requirements into concrete engineering requirements, and working with the Manufacturing and Service groups in mind as the customer.

SALARY AND PAY TRANSPARENCY Salary range for this position is between $160,000 and $180,000.  Base pay is dependent upon many factors, such as :

• training, transferable skills, work experience, education, business needs and market demands.
• The base pay range is subject to change and may be modified in the future.
• This role may also be eligible for bonus, equity, and all applicable company benefits.
• The salary range and / or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.
• ESSENTIAL DUTIES & RESPONSIBILITIES Act as the primary Hardware Engineering liaison to Quality and Manufacturing Engineering teams in support of sustaining production activities.
• Lead NCR investigations on behalf of Engineering, participate in MRB review meetings, and implement resulting CAPAs.
• Provide root cause analysis for failures, and propose design improvements to mitigate those failures.
• Directly contribute to design improvements of systems and processes for production released products, including DFMA and cost reduction efforts.
• Perform verification testing for electromechanical subsystems & components, including cable assemblies in accordance with medical device regulatory standards (IEC-60601).
• Write technical documentation including design specifications, design reviews, test protocols, quality inspection procedures, ECR / ECO submissions, etc.
• Contribute to product development activities including owning hardware design, defining and performing engineering studies, test and assembly fixture design and automation, while working closely with cross-functional teams.
• Provide engineering guidance and mentorship to junior staff, implement best practices, and lead by example with a high standard of engineering design diligence.
• Own relationships and provide engineering support to key vendors and product stakeholders.
• PREFERRED QUALIFICATIONS 8+ years of related experience with a Bachelor’s degree or 6+ years and a Master’s degree Strong understanding of hardware engineering concepts (mechanical, electrical, firmware, robotics, etc.) Strong background in hardware NPI, including design controls and phased product development from prototype to manufacturing transfer.
• Proven track record of developing commercialized products.
• Medical device preferred.
• Technical writing experience (test protocols and reports, manufacturing drawings and instructions, etc.) Experience using Arena PLM, Jira, Bitbucket, and other design controls tools.
• Experience with CAD, GD&T, and mechanical drawing detailing (Solidworks preferred) Experience with PCB schematic and layout design (Altium preferred) Experience with medical device development, manufacturing, and regulatory compliance preferred (IEC 60601, ISO 13485, ISO 14971, FDA CFR821) QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the knowledge, skill, and / or ability required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Education / Experience Typically requires a minimum of 6 years of related experience with a Bachelor’s degree; or 4 years and a Master’s degree; or a PhD with 2 years experience; or equivalent experience.
• Language Ability to read, analyze, and interpret professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
• Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.   Physical Requirements 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; use hands to finger, handle, or feel; reach with hands and arms and talk or hear.
• The employee must occasionally lift and / or move up to 50 pounds and frequently lift and / or move up to 20 pounds.
• Specific vision abilities required by this job include color, distance and close vision.
• Work Environment The work environment characteristics described here are representative of those an employee encounters while performing 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 frequently exposed to work near moving mechanical parts.
• The noise level in the work environment is usually moderate.

Benefits :

Plus, we work to maintain the best possible environment To Apply :