Director, Hardware Engineering

Director Of Hardware Engineering

The Director of hardware engineering will work closely with engineering, software, product marketing, program and project management as well as supporting functional groups such as clinical, quality, regulatory and operations on current and future Ulthera platforms. The Director of hardware engineering will have broad experience for electromechanical devices in the aesthetic or medical device space integrating mechanical, electrical, software, and firmware subsystems. The Director will, in a team environment, ensure product compliance for quality & regulatory standards, adherence to product requirements, reliable designs and cost containment. This will be done by organizing and actively managing both internal hardware engineering resources and external engineering design partners, meeting schedule timelines and project milestones. The Director has authority to sign-off on R&D related documents in the quality system, NDA's and contracts and PO's less than $50k.

Job Purpose Statement:

This position will work closely with engineering, software, product marketing, program and project management as well as supporting functional groups such as clinical, quality, regulatory operations, and advanced development on current and future Ulthera platforms. In addition to collaborating with other functional groups, the Director, Hardware Engineer must establish a clear vision for hardware development and new features for existing product roadmaps by leading an internal hardware team of electrical, mechanical and transducer engineers. Works in conjunction with other R&D Departments and Technical Operations to ensure project plans are achieved within budget, timeline, and in accordance with Regulatory and Quality Standards, and Company SOPs to support for IDE, 510K and Tech file submissions.

Essential duties and responsibilities:

Technical Leadership:

• Working with stakeholders coordinate hardware system, electrical, mechanical, and industrial design requirements necessary to satisfy customer and design needs. Coordinate and write hardware engineering design documentation.
• Lead the hardware team through all levels of development activities from concept to design transfer.
• Complete full system, electrical, mechanical design verification and prepare test objective evidence for full system level tracing for projects and feature rollouts.
• Work with all needed engineering and marketing disciplines to confirm full system level verification. Work to provide objective evidence of compliance to specifications.
• Ensure the hardware team performs duties according to Merz SOPs and enhance necessary SOPs to improve efficiency and quality.

Technical:

• Work with design engineers to solve complex electrical, mechanical and industrial design challenges to satisfy system requirements and features.
• Deliver technical solutions on-time, in-scope, and on-budget.
• Manage and lead system integration including electrical, mechanical and software subsystems for new products and features through proper verification test planning, execution, and reporting.

Regulatory Submission Support:

• Collaborating with regulatory department provide support for submissions in the form of documentation, reports, and specific content for submission documents

Technical Roadmap:

• Develop and execute system technical vision, solutions, and present progress to senior management.
• Jointly create hardware product roadmap with marketing and senior management.

Innovation:

• Innovate and create novel solutions to establish unique customer solutions and create barriers of entry for aesthetic competitors

Collaboration:

• Collaborate and problem solve with other functional groups to determine solutions with optimal risk and reward profile.
• Identify possible design partners and critical subject matter expertise necessary to accomplish product vision

Professional experience:

• 10+ years of experience in highly regulated industry (e.g. medical devices).
• Proven history of releasing innovative products which require electrical, mechanical and software engineering disciplines
• Prior experience working as a technical and functional lead, systems engineer and manager.

Knowledge, skills and abilities:

• Demonstrated ability to understand electromechanical device including mechanical, electrical and software from a system level perspective.
• Demonstrated ability to lead system level design for electromechanical devices interfacing with cross-functional teams consisting of R&D engineering, marketing, clinical, regulatory, and quality.
• Ability to write system requirements necessary to guide designs as well as the product development process.
• Demonstrated ability to collaborate and influence others to meet project objectives.
• Demonstrated ability to collaborate with Customers translating their needs into realizable product solutions resulting in engineering requirements.
• Experience in design of electrical-mechanical systems or devices.
• Demonstrated problem solver as well as ability to identify and show unique and innovative solutions.
• Design optimization for performance, COGs, reliability, and time-to-market.
• Knowledge of tolerance analysis in designs.

Knowledge of methods:

• Knowledge of design controls (e.g. 21 CFR 820:30)

Preferred:

• Familiarity in using FEM tools (e.g. ANSYS) to solve engineering problems

Personal skills:

• Excellent verbal and written communication as well as problem solving skills
• Must be proficient in MS Word, Excel, and PowerPoint

Education:

• B.S or B.A. in engineering

Preferred:

• Master's degree in engineering