Director, Hardware Engineering
Company: Merz North America, Inc.
Location: Mesa
Posted on: May 27, 2023
Job Description:
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 documentsTechnical Roadmap:
- Develop and execute system technical vision, solutions, and
present progress to senior management.
- Jointly create hardware product roadmap with marketing and
senior management.
- Innovate and create novel solutions to establish unique
customer solutions and create barriers of entry for aesthetic
competitors
- 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 visionProfessional
experienceRequired:
- 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
abilitiesRequired: -
- 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
methodsRequired:
- Knowledge of design controls (e.g. 21 CFR 820:30)Preferred: -
- Familiarity in using FEM tools (e.g. ANSYS) to solve
engineering problemsPersonal skillsRequired:
- Excellent verbal and written communication as well as problem
solving skills
- Must be proficient in MS Word, Excel, and
PowerPointEducationRequired:Preferred:Equal Opportunity
Employer/Protected Veterans/Individuals with DisabilitiesThe
contractor will not discharge or in any other manner discriminate
against employees or applicants because they have inquired about,
discussed, or disclosed their own pay or the pay of another
employee or applicant. However, employees who have access to the
compensation information of other employees or applicants as a part
of their essential job functions cannot disclose the pay of other
employees or applicants to individuals who do not otherwise have
access to compensation information, unless the disclosure is (a) in
response to a formal complaint or charge, (b) in furtherance of an
investigation, proceeding, hearing, or action, including an
investigation conducted by the employer, or (c) consistent with the
contractor's legal duty to furnish information. 41 CFR
60-1.35(c)
Keywords: Merz North America, Inc., Mesa , Director, Hardware Engineering, Executive , Mesa, Arizona
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