IRRAS is globally selling IRRAflow®, numerous supporting accessories and just launched its second product line, Hummingbird®. IRRAS is making decisive moves to internalize product research, design, development, manufacturing, and testing. IRRAS requires a seasoned Director of Engineering who has a solid foundation across many technical, fiscal, and program management disciplines, e.g. medical devices & sterile disposables, budgeting, product life cycle, and direct staff management & department growth.
The Sr. Director of Engineering is a leader and key member of the Management Team. The person is driven by delighting internal & external customers and energized when their staff and processes are visibly improving. Demonstrating exceptional resource efficiency and rapid work throughput with sound engineering judgment and closed loop systems are paramount. This position is multi-faceted, requiring an individual with success across a broad range of medical device technical design & manufacturing and management experience. This person shall be a mentor to direct staff, highly collaborative colleague with their peers, sought-after subject matter expert for senior staff, and a Commercial Team “go to” for technical customer support. These expectations demand a person who is naturally balanced, calm, rational, and demonstrates strong associative thinking skills. They need to be an organization and department ballast. This individual shall have a healthy sense of skepticism which creates and promotes a technical culture of failing forward fast and quick incremental learning cycles. This position shall build from their existing and extensive engineering network to create a reliable and cost-effective engineering team which delivers best in class solutions that are aligned to the overall corporate goals and margin expectations of the company. This person shall work under minimal supervision and from generally stated corporate and department objectives. This individual shall have a quality oriented and self-driven nature. This role shall make a significant positive impact on product quality, performance, innovation, and confidence in roadmap delivery to increase the company and shareholder value.
- Selects, trains, motivates, and creates a high performing staff who delivers as promised, keeps quality foremost, embraces best practices, and assures compliance is maintained
- Assures product and technical documentation compliance with ISO 13485:2016, ISO 14971:2012 & 2019, Titles 21 CFR 801, 803, 806, and 820, European Union MDD/MDR regulations, MDSAP and compliance in other required global markets, e.g. Japan and Brazil
- Owns the cross-functional product life cycle management process, which augments a core of medical device design controls with research & ideation plus product end of life & retirement.
- Responsible for product research, development, validation, and seamless manufacturing transfer
- Acts an ambassador for and demands adherence to program management, design controls, technical documentation, and quality assurance discipline
- Operates as a conduit between engineering and other functions, i.e. Quality, Regulatory, Operations, and Commercial Functions
- Prepares and administers the Department goals/objectives and budget, provides quarterly 12 month rolling forecast updates, and drives the necessary cost controls and elimination of barriers
- Facilitates initiatives for innovation in ways of working, fiscal management, process efficiency, product performance, and technologies to increase efficiency and reduce cost
- Judiciously performance manages outside engineering partners and consultants via best practices, e.g. Statements of Work (SOW), negotiated rates, and deliverable based payments
- Advance identifies risks and drives the organization to make informed risk managed decisions
- Follows disciplined engineering methodologies such as trace matrices, design reviews, design and process FMEAs, tolerance studies, CFD (Computational Fluid Dynamics) analysis, material analysis and durability testing, manufacturing pilot builds, and usability studies
- Ensures all engineering activities supporting Post Market Surveillance (PMS) are timely addressed and implemented with sound technical solutions
- Actively investigates customer and competitor Intellectual Property (IP); directly supports or leads IP submissions and office actions responses; may be oversee portions of the IRRAS IP portfolio
- Assists Senior Management with refining and executing the product roadmap
- Carries out other duties when reasonably instructed
EDUCATION & EXPERIENCE:
- Small to medium size business experience with an entrepreneurial spirit
- Bachelor of Science degree in mechanical or electrical engineering
- 12-15 years core competency experience as a technical department and program manager
- A career of successfully developing, commercially launching, and sustaining sterile & console medical devices while building high performing project teams and developing people into leaders
- Solid understanding of how engineering activities affect the organization’s P&L
- Experience developing, executing, and delivering an engineering excellence strategy
- Proven track-record of effectively managing outside engineering resources
- Established network of broad and cost-effective technical resources
- Views issues from a total business perspective with strong communication skills
- Competence with fluid mechanics and electro-mechanical & sterile medical devices
- Hands on experience with engineering analysis tools and instruments, e.g. testing hydraulic valves, plastic, and electro-mechanical assemblies under a variety of stress conditions that test pressure, temperature, flow, humidity, stress, creep, EMI, power, life cycle, reliability, etc.
- Strong administrative skills with Microsoft Project, Word, Excel, PowerPoint and Visio, CAD, statistical, stress, mold flow & fluid analysis, and configuration & change management.
- Able to establish trusted customer relationships and translate customer needs into specifications
- Enthusiastic orientation toward cost reduction and quality improvement projects
- Effective working knowhow of phase gate processes in a medical device environment
- Ability to synthesize complex issues, determine solutions, and implement difficult decisions
- A Master of Science Degree
- Experience with CFD analysis and the ability to practically apply insights from this analysis
- SolidWorks literacy is preferred
- Implementation experience with Product Data Management (PDM) Systems, e.g. Windchill
- Six Sigma Green or Black Belt is beneficial
- Experience with statistical analysis tools such as Minitab or JMP are a plus.
- Successful management of internationally dispersed resources in a global company
- Believes in and practices the meaning of Filotimia
- Impeccable attention to detail
- Strong analytical and problem-solving skills with impeccable attention to detail
- Strong computer proficiency including Microsoft Project, Word, Excel, Visio and PowerPoint
- Excellent verbal, written, and presentation communication skills
- Performance Orientation – Is driven by personal performance; achieves all objectives detailed in IRRAS Department goals and comfortable with quantifiable assessments.
- Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
- Competitive – Dedicated to a competitive spirit that supports the IRRAS goal to be the premier Medical Device company in the industry.
- Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.
- Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty.
- Confidence – Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.
- Multitasking – Capable of performing multiple tasks over a certain period of time by executing them concurrently.
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 talk or hear. The employee is frequently required to sit.
- The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Transition from standing and sitting often.
- Required specific vision abilities might include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee might occasionally lift and/or move up to 10 pounds.
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.
- General office and test lab environments
- Daily exposure to computers
- The noise level in the work environment is usually moderate
- Travel can be required
The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
If you are interested in applying for employment with IRRAS please apply here.