Director of Engineering - Design
Director of Engineering - Design
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$ 185000 - 210000
1 Vacancy
Job Description
ABOUT SANISURE
SaniSure is a multinational manufacturer of singleuse bioprocessing solutions (SUT) used in the production of biological including monoclonal antibodies cell therapies gene therapies and vaccines. With operations in the U.S. and in Europe SaniSure operates a leading platform of vertically integrated critical fluid management technologies and integrated solutions. Its singleuse products and system solutions are sold to global pharma and biotech companies and are used from R&D through fullscale commercial cGMP manufacturing of among the most innovative large molecule therapeutics and vaccines. This role is expected to be onsite.
We continue to be on a robust growth trajectory via both organic and inorganic growth as the company capitalizes on increasing global demand and continues its transition from a component manufacturer to an integrated systems and solutions provider.
Our primary offering includes highvalue assembly solutions and a portfolio of marketleading products including PharmaTainer bottles and carboys and related assemblies Mixed4Sure mixing solutions Flex4Sure bags and bag assemblies Fill4Sure needles and needle assemblies fittings clamps and a wide range of silicone braided and thermoplastic tubing solutions. The company has a growing portfolio of innovative solutions serving fastgrowth applications such as cell and gene therapies.
SaniSure is a highgrowth nimble and innovative company with a strong customer and market focus. Join us and grow your career at SaniSure!
SUMMARY:
The Director of Engineering Design is responsible for global product design at SaniSure. Scope includes:
- Selecting and deploying software training design tools and design libraries.
- Plastic component tooling design and fabrication.
- Assuring efficiency of drawing and Bill of Material throughput while maintaining accuracy and quality.
- Engineering data integrity and services and the Engineering portions of product change control and change management.
ESSENTIAL FUNCTIONS:
- Manage the global team responsible for computeraided design (CAD) at SaniSure. Set and continuously improve global CAD standards templates and design libraries and assure deployment and training.
- Develop deep product knowledge to provide technical expertise to Sales Customers and other functional areas.
- Analyze mechanical designs including sketches technical drawings schematics specifications and associated product measurements. Conduct risk assessments using FMEA framework and drive risk mitigations as required. Lead design and drawing reviews as needed.
- Assist engineering personnel with material sourcing for new parts in support of these designs.
- Obtain and assemble data including product data sheets and material quotes to complete drawings and bills of materials (BOMs).
- Managing plastic component tooling design and fabrication.
- Ensure full technical documentation of designs including BOMs drawings schematics engineering change control and procedures adhere to customer requirements industry regulations and quality standards.
- Assure efficient prioritization and task management. Directly engage in ongoing oversight of turnaroundtimes for drawings and BOMs. Drive the global team to meet or exceed their objectives for established metrics and Targets To Improve (TTIs) especially time commitments while maintaining accuracy.
- Work with R&D New Product Introduction and with Manufacturing to integrate a Design for Manufacture & Assembly (DFMA) and Design to Cost (DTC) perspective.
- Maintain organized and controlled records of all drawings and BOMs. Drive and facilitate assigned portions of product change management and control.
- Own data integrity and data services when it comes to item master creation and curating of assigned product data within SaniSure databases. This includes Product Data Management (PDM) and ERP.
- Support product configuration management.
- Collaborate with crossfunctional teams along with product and project management. Develop and maintain positive rapport and working relationships with other personnel across the organization in support of initiatives to execute product improvements and enhancements.
- Provide technical direction and guidance to less experienced Engineers and Drafters.
- Perform other duties as assigned.
QUALIFICATIONS:
- Bachelors degree in Engineering; Masters preferred.
- Minimum 10 years of overall Engineering experience.
- Minimum 5 years in a former role managing a team of Engineers.
- Experience with staffing and with growing and developing strong teams.
- Experience setting topdown department goals and objectives tied to business metrics and driving team performance in the context of business results.
- Expert knowledge and demonstrated handson experience with Solidworks CAD software both 3D and 2D.
- Expert knowledge with plastic component and tool design especially injection molding and some blow molding.
- Able to read and comprehend and interpret documents such as drawings BOMs blueprints and operating procedures. Able to train and guide less experienced personnel on proper interpretation and best practices.
- Basic understanding of mathematical fundamentals of plane and solid geometry fractions percentages ratios and proportions to practical situations.
- Design control change control and risk management experience (FMEA).
- In depth knowledge of creation of 2D and 3D drawings and related Bill of Materials (BoMs).
- Able to interpret a variety of instructions furnished in written oral diagram or schedule form.
- Strong MS Office skills including Excel.
- Familiar with project management software.
- Strong ERP knowledge SyteLine preferred.
- Excellent oral and written communication skills.
- Patient tactful diplomatic and approachable.
- Able to stay calm in challenging situations.
- Keen sense of urgency and ability to deliver ahead of deadlines.
- Strong organizational skills and attention to detail.
- Able to establish and maintain effective working relationships.
- Able to effectively work in a fastpaced environment and frequently manage multiple priorities.
- Must be selfmotivated amendable to a variety of work projects and work efficiently independently and as part of a team.
- Excellent followup skills.
PREFERRED QUALIFICAIOTNS
- Single Use Consumable design and development experience
- Experience working with multiple bioprocessing equipment suppliers.
- Biotech device development experience.
SaniSure is an Equal Employment Opportunity Employer.
SaniSure does not unlawfully discriminate on the basis of the race religion color national origin citizenship ancestry physical or mental disability legally protected medical condition (cancerrelated or genetic characteristics or any genetic information) marital status sex gender sexual orientation gender identity gender expression pregnancy age military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process please contact us by email atand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a casebycase basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Required Experience:
Director
Employment Type
Full Time
