Sr. MFG & Process DVL Engineer

Senior Product Development Engineer

Staff Engineer – Devices

Sr Manufacturing Process and Development Engineer (Automation)

Responsibilities: <ul><li>Participates in the Design and Development of tools and molding processes to support the development of new products.</li><li>Provides support in product development, manufacturing optimization designs, tooling sampling, product samples, and prototypes.</li><li>Determines the most suitable manufacturing concepts for tooling related to forecasted production quantities, quality requirements, and manufacturing location</li><li>Responsible for collaborating with global experts (CoE molding) to continuously update and improve operational standards regarding plastic injection molding</li><li>Responsible for providing budgets for new tools and molding processes.</li><li>Responsible for ensuring, together with the multidisciplinary team, that molds and processes are designed to produce high-quality products efficiently and effectively with the lowest possible cost.</li><li>Responsible for coordinating and tracking engineering changes to injection molds.</li><li>Responsible for supporting the management of resources for the mold shop area.</li><li>Responsible for participating in the Plants Continuous Improvement Programs.</li><li>Provides support in analyzing tooling and equipment capacities for new part numbers and changes in quoted volumes.</li><li>Responsible for participating in the development of new products, engineering changes for molds, ensuring adherence to engineering and internal standards.</li></ul> Requirements: Preferred Years of Experience / Minimum Qualifications: <ul><li>Bachelor’s degree in Mechanical Engineering or similar.</li><li>5+ years of experience in a similar role.</li><li>Team management experience.</li></ul> Required Skills and Competencies: <ul><li>Proficiency in design software (CAD): Creo (Pro-E), SolidWorks, Space Claim, AutoCAD, CATIA (preferably).</li><li>Proficiency in machining software (CAM): Creo ProNC, Mastercam, SolidCam (preferably).</li><li>Proficiency in plastic filling simulation software (CAE): Moldflow, Autodesk Moldflow, ANSYS.</li><li>Basic knowledge of plastic injection molding processes.</li><li>Strong knowledge in tool manufacturing, tool steel application/selection, heat treatment, and plating/coating.</li><li>Strong understanding of polymer technology, particularly engineering-grade resins.</li><li>Knowledge of Scientific Injection Molding and/or Mastermolding Certification (desirable).</li><li>Knowledge of Six Sigma and LEAN principles.</li><li>Knowledge of geometric tolerances.</li><li>Strong project management skills, with the ability to handle multiple projects simultaneously.</li><li>Understanding of practices, terminology, and tolerances associated with manufacturing, machining, grinding, wire EDM, casting, etc.</li><li>Availability to travel (25% of the time).</li><li>Proficiency in Microsoft Office Suite.</li><li>Knowledge of SAP.</li><li>Ability to exercise effective leadership.</li><li>Ability to read specialized reports (scientific and technical papers, legal reports).</li><li>Intermediate - Advanced English proficiency (85%).</li><li>Applicable knowledge for the position in IATF 16949 and ISO 14001.</li><li>Knowledge of the company’s safety regulations and environmental management system.</li></ul>

Responsibilities: <ul><li>Monitors the external market and is a key supporting team member in the development of disruptive products to enhance the Company’s product offering.</li><li>Maintains communication with technical staff and field operations to be proactive in identifying performance and failure trends.</li><li>Identifies opportunities for technological improvements/modifications to the Company’s product line and submits recommendations for sustainable engineering projects and new R&amp;D projects</li><li>Performs complex design and drafting of new and existing parts/assemblies.</li><li>Prepares, checks, and maintains engineering documentation.</li><li>Performs advanced engineering calculations and simulations.</li><li>Leads Engineering projects by conducting tests/experiments, collecting information, and analyzing results.</li><li>Provides technical input related to products and performance, both internally and externally.</li><li>Works effectively with vendors from initial prototype manufacturability studies to mature product support and optimization</li><li>Serve as mentor to more junior engineers to ensure all Engineering tasks are completed in accordance with established organizational processes and Engineering requirements</li><li>Supports and collaborates with other departments within the organization.</li></ul> Requirements: Minimum Qualifications: <ul><li>B.S. in Mechanical Engineering or related four-year degree.</li><li>7+ years of experience as a mechanical engineer with relevant mechanical design experience.</li><li>Eligible to drive Company or personal vehicle for Company purposes including the ability to meet requirements of the Company’s Vehicle Use Agreement and Driving.</li></ul> Policy Preferred Qualifications: <ul><li>Experience with SolidWorks and SolidWorks Simulation, or similar programs.</li><li>Proven track record of innovative design solutions and problem-solving skills.</li><li>Proficient in CAD/FEA software.</li><li>Strong computer skills with ability to utilize discipline specific-software applications to drive efficiency in productivity</li><li>Must be self-motivated, with the ability to oversee and motivate others and influence decisions, capable of identifying problems and recommending alternative solutions</li><li>Must be a self-starter able to take initiative, make decisions and drive for results.</li><li>Must demonstrate a high level of professional integrity and demeanor.</li><li>Strong written and oral communication skills with demonstrated ability to conduct effective presentations and written report preparation.</li><li>Able to effectively make technical decisions and manage change requests.</li><li>Ability to manage time effectively, think strategically and translate concepts into action plans and track results.</li><li>Ability to build engaging relationships at all levels of the organization as well as with customers.</li><li>Ability to work independently as well as part of a team, managing multiple tasks and projects simultaneously to meet challenging deadlines.</li><li>Experience leading projects and performing increased job responsibilities over time.</li></ul>

Responsibilities: Design &amp; Development: <ul><li>Lead the design and development of drug combination products by understanding design space and managing critical design parameters.</li><li>Utilize SolidWorks and apply design for manufacturing (DFM) principles along with geometric dimensioning and tolerancing (GD&amp;T) to create sound engineering drawings.</li><li>Identify the best tools and approaches to effectively solve engineering problems.</li><li>Develop, optimize, and analyze designs using a combination of engineering principles, analytical methods, and experimental techniques.</li></ul> Technical Support &amp; Compliance: <ul><li>Support the evaluation and assessment of new technologies, intellectual property, products, and processes.</li><li>Provide support for existing products in terms of quality, manufacturing, and cost improvement.</li><li>Execute technical and cross-functional project work to ensure successful product development.</li><li>Develop and implement detailed test methods and write comprehensive technical reports based on design verification testing for design changes and product design activities.</li><li>Collaborate effectively with laboratory technicians and support staff.</li><li>Ensure compliance with quality policies, standard operating procedures, and regulatory requirements.</li></ul> Requirements: Regulatory &amp; Validation Expertise: <ul><li>Knowledge of Factory Acceptance Testing (FAT), Process Validation, and Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ).</li><li>Understanding of U.S. regulatory and quality requirements, including 21 CFR 820.3</li></ul> Experience: <ul><li>Minimum 8 years of engineering experience, with a preference for at least 5 years in product development.</li><li>Strong understanding of disciplined product development processes and quality requirements.</li><li>Experience in statistical tools, computer analysis, and engineering fundamentals for problem-solving.</li><li>Proficiency in SolidWorks is required.</li></ul> Skills &amp; Competencies: <ul><li>Strong interpersonal skills with the ability to collaborate effectively.</li><li>Excellent technical judgment and problem-solving abilities.</li><li>Demonstrated accountability for the successful completion of assigned tasks.</li></ul>

Responsibilities: <ul><li>Non-standard automatic equipment design and development, execute machine mechanism detail design and drawing, build, and execute automation design standard.</li><li>Handle machine or auto assembly line establish by external automation suppliers.</li><li>Platforming manufacturing process development.</li><li>Challenge product design for manufacturability and cost feasibility.</li><li>Launch product at rate through FACA/QCPA tools (yield, CPK, OEE…)</li><li>Launch product on time with cross function team.</li><li>Process documentation (DFM，FMEAs, WI, FACA/QCPC…)</li></ul>&nbsp;Requirements: <ul><li>Bachelor or above degree in mechanical engineering or related background.</li><li>5+ years automation design/development knowledge / experience. Can complete machine mechanism design independently.</li><li>Familiar with mechanical, pneumatic, servo component selection; Understand machining principle of precision parts well.</li><li>Familiar with Creo or SolidWorks or AutoCAD design software</li><li>Data oriented issue finding and problem-solving skills. Knowledge of quality control and quality issue analysis and improvement</li><li>Fluent in using of basic process development related tools like DFM, PFMEA，DOE，FAA, CTAR</li><li>Good logical thinking, teamwork, and innovation consciousness; powerful sense of responsibility。</li><li>Fluent in written and Spoken English.</li><li>Oversea working experience is a plus.</li></ul>

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Sr. MFG & Process DVL Engineer

Senior Product Development Engineer

Staff Engineer – Devices

Sr Manufacturing Process and Development Engineer (Automation)

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Sr. MFG & Process DVL Engineer

Senior Product Development Engineer

Staff Engineer – Devices

Sr Manufacturing Process and Development Engineer (Automation)

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