Principal/Staff Engineer - Process Development, CVD/Diffusion

Associate Director RA & QA

Principal R&D/Product Development Engineer (Remote)

Responsibilities: <ul><li>Develop and optimize unit processes to meet yield and quality targets for advanced NAND devices</li><li>Evaluate innovative process and equipment solutions for early experimentation and process margin improvement</li><li>Collaborate with Singapore-based Diffusion manufacturing teams to identify and prioritize key technology challenges</li><li>Integrate and troubleshoot processes within cross-functional teams focused on yield and quality enhancement</li><li>Partner with Boise TD Films teams to align future device requirements with process capabilities</li><li>Identify disruptive process technologies early and define viable implementation paths with global TD and manufacturing teams</li><li>Conduct fundamental research, hardware evaluations, and novel process testing to support intellectual property generation</li><li>Design and execute experiments to expand process margins and validate manufacturability of next-node solutions</li><li>Lead cross-functional initiatives to simplify processes and implement improvements</li><li>Embed best-known manufacturing practices into early-stage development of new nodes</li><li>Develop and apply advanced process monitoring and control methodologies.</li><li>Serve as a technical expert, contributing to process, equipment, and procedural improvements</li><li>Lead multidisciplinary projects across teams, sites, and suppliers focused on quality, yield, cost, and productivity</li><li>Advise management on significant technical issues and drive innovation through patents and technical publications</li><li>Maintain strict adherence to our client Intellectual Property protection policies</li><li>Engage continuously with global TD partners and suppliers to push for breakthrough solutions</li><li>Own and manage module-level business processes</li></ul> Requirements: <ul><li>Bachelor/Masters in Materials Science, Electrical/Electronics, Chemical, Microelectronic Engineering, Physics with minimum 5 years of relevant experience or PhD in Materials Science, Electrical/Electronics, Chemical, Microelectronic Engineering, Physics</li></ul> Strong understanding of: <ul><li>Flow dynamics, thermodynamics, and physical phenomena in deposition</li><li>Precursor depletion effects in 3D structures and mitigation strategies</li><li>Interface characterization techniques (e.g., SIMS, XPS, EDX, SEM/TEM)</li><li>Integration and structural constraints in film deposition processes</li><li>Memory process flows, especially for planar and vertical NAND</li><li>Proficiency in data analysis tools (e.g., Y3) and Design of Experiments (DoE)</li><li>Excellent communication skills for both in-person and remote interactions</li><li>Self-motivated, adaptable, and capable of managing multiple projects in a dynamic environment</li></ul>

Role Description: <ul><li>The Associate Director – Regulatory Affairs (CA) will lead the development and execution of regulatory strategies to support the timely approval, lifecycle management, and commercialization of generic pharmaceutical products in Canada. </li><li>The role will focus heavily on Abbreviated New Drug Submissions (ANDS) and Supplemental ANDS filings, while acting as the primary interface with Health Canada for regulatory discussions, clarifications, and negotiations.</li><li>This position plays a critical strategic role in new product development, portfolio expansion, and in-licensing evaluation, ensuring all regulatory activities align with Health Canada requirements, corporate objectives, and market access timelines.</li><li>The Director will also support portfolio maximization (PMX) initiatives, identify regulatory opportunities, and oversee a small regulatory team.</li></ul> Responsibilities: Regulatory Strategy &amp; Leadership <ul><li>Develop and implement regulatory strategies for ANDS submissions to Health Canada that maximize probability of approval and accelerate time to market.</li><li>Provide strategic regulatory guidance during product selection and development phases, including formulation, bioequivalence, and labeling strategy.</li><li>Ensure regulatory considerations are integrated into R&amp;D, clinical, CMC, and commercial planning.</li><li>Advise senior leadership on Canadian regulatory landscape, evolving guidelines, and approval pathways.</li><li>Lead regulatory planning for first-to-file, complex generics, and niche opportunities where applicable.</li></ul> Health Canada Engagement &amp; Regulatory Submissions <ul><li>Serve as the primary liaison with Health Canada, maintaining professional and proactive relationships with regulatory authorities.</li><li>Lead preparation and submission of: o Abbreviated New Drug Submissions (ANDS)</li><li>Supplemental ANDS (SANDS)</li><li>Notifiable Changes</li><li>Post-approval regulatory filings</li><li>Manage Health Canada deficiency responses, clarification requests, and review cycles.</li><li>Coordinate cross-functional teams to ensure high-quality regulatory dossiers</li><li>Represent the company in Health Canada meetings, scientific advice discussions, and regulatory negotiations.</li><li>Track and interpret Health Canada guidance updates, policy changes, and regulatory precedents affecting generic drug approvals.</li></ul> In-Licensing &amp; Regulatory Due Diligence <ul><li>Conduct regulatory due diligence for potential in-licensing and partnership opportunities.</li><li>Evaluation of regulatory pathways and submission feasibility</li><li>Data package completeness</li><li>Bioequivalence strategy</li><li>Intellectual property and exclusivity considerations</li><li>Estimated approval timelines and risks</li><li>Provide regulatory risk assessments and strategic recommendations to senior management during deal evaluation.</li><li>Support technology transfer and regulatory integration of licensed products into the company’s Canadian portfolio.</li></ul> Portfolio Management &amp; Lifecycle Optimization <ul><li>Support portfolio maximization (PMX) initiatives, including o Label expansions</li><li>New strengths and dosage forms</li><li>Site transfers</li><li>Manufacturing changes</li><li>Competitive lifecycle strategies</li><li>Identify regulatory opportunities to extend product lifecycle or improve market competitiveness.</li><li>Partner with commercial, market access, and supply chain teams to align regulatory activities with business objectives.</li></ul> Cross-Functional Collaboration <ul><li>Work closely with internal teams including o R&amp;D / Formulation Development</li><li>Clinical &amp; Bioequivalence</li><li>Quality Assurance / Quality Control</li><li>CMC / Manufacturing</li><li>Intellectual Property</li><li>Business Development</li><li>Provide regulatory input during product development milestones and technical reviews.</li><li>Ensure regulatory compliance with Health Canada, ICH, and global regulatory standards.</li></ul> Team Leadership &amp; Development <ul><li>Lead, mentor, and develop 1–3 regulatory associates/managers.</li><li>Oversee work allocation, submission timelines, and performance development.</li><li>Build a high-performance regulatory function capable of managing increasing submission volume.</li><li>Promote a culture of accountability, quality, and regulatory excellence.</li></ul> Requirements: Education &amp; Experience <ul><li>Advanced degrees in Pharmacy, Life Sciences, Pharmacology, Regulatory Affairs, or related discipline.</li><li>Regulatory certification (e.g., RAC) is considered an asset.</li><li>15–20 years of regulatory affairs experience within the pharmaceutical industry.</li><li>Extensive experience with Canadian regulatory submissions, particularly:</li><li>ANDS</li><li>SANDS</li><li>eCTD filings</li><li>Demonstrated experience interacting directly with Health Canada.</li><li>Strong understanding of Generic drug approval pathways</li><li>Bioequivalence requirements</li><li>CMC regulatory expectations</li><li>Experience supporting business development or in-licensing regulatory evaluations.</li><li>Previous team leadership or mentoring experience preferred.</li></ul> Core Competencies <ul><li>Strategic Thinking Ability to translate regulatory requirements into business-focused strategies that accelerate approvals and strengthen the company’s competitive position.</li><li>Regulatory Expertise Deep knowledge of Health Canada regulatory frameworks, ANDS requirements, and generic drug approval processes.</li><li>Stakeholder Influence Proven ability to engage effectively with regulatory authorities, internal leadership, and external partners</li><li>Physical Requirements</li></ul> Physical &amp; mental requirements: <ul><li>Business travel (15% of time), driving as part of work responsibilities.</li></ul>

Responsibilities: <ul><li>Lead the development of sockets, high-speed connectors, and cable assemblies from market definition to production release.</li><li>Collaborate with cross-functional teams (sales, applications, field engineers, project managers) to translate Voice of Customer (VOC) into technical concepts and specifications.</li><li>Conduct feasibility studies and generate design concepts.</li><li>Perform mechanical and thermal simulations.</li><li>Present design evaluations and proposals to customers.</li><li>Create detailed 2D/3D designs, DFMEA, and tolerance analyses.</li><li>Build and validate prototype samples.</li><li>Finalize product qualification and specifications.</li><li>Provide ongoing technical support to Operations, Quality, and Production teams.</li><li>Manage Engineering Change Notifications (ECN) and Product Change Notifications (PCN).</li><li>Maintain system-level understanding of customer applications and integrate solutions into the design process.</li><li>Drive projects through the LEANPD stage-gate process to ensure timely delivery of high-quality, cost-effective solutions.</li><li>Coordinate with manufacturing, procurement, and external suppliers to align with technical, quality, and cost targets.</li><li>Generate and manage all necessary technical documentation including design drawings, engineering changes, and design history files.</li><li>Support post-launch activities and continuous improvement initiatives.</li></ul> Requirements: <ul><li>Bachelor’s degree in Mechanical Engineering or equivalent work experience.</li><li>10+ years of relevant mechanical engineering experience involving:</li><li>Electrical components and devices.</li><li>Mechanical structure design.</li><li>Manufacturing tooling development (stamping, molding, assembly, plating).</li><li>Manufacturing process development.</li></ul> Strong knowledge in: <ul><li>Socket, connector, and cable assembly design.</li><li>Material selection.</li><li>Tolerance analysis.</li><li>DFMEA.</li><li>Product qualification.</li></ul> Expertise in 3D CAD applications (preferably Creo), including: <ul><li>3D solid modeling (sheet metal).</li><li>2D drawings.</li><li>PDM Link Data Manager.</li><li>General understanding of SpaceClaim, SolidWorks, or other conceptual design tools.</li></ul> Advanced proficiency in: <ul><li>Geometric Dimensioning &amp; Tolerancing (GD&amp;T).</li><li>Limit and fit analysis including statistical tolerance analysis.</li><li>Finite element analysis tools (e.g., Ansys, Workbench) for elastic and plastic behavior of metals.</li></ul> Proven ability to: <ul><li>Develop and write design objectives and technical product specifications.</li><li>Lead product development from concept to production.</li><li>Provide technical leadership across the full product lifecycle.</li></ul> In-depth knowledge of manufacturing processes: <ul><li>Machining, molding, stamping, plating, assembly.</li><li>Best practices in Design for Manufacturing (DFM).</li><li>Solid understanding of competitive product landscape and intellectual property considerations.</li><li>Fluent in English (verbal and written) to support global communication.</li><li>Comfortable working in a global, cross-functional team and across time zones.</li><li>Strong analytical and problem-solving skills; able to make data-driven decisions with minimal supervision.</li><li>Proficient in MS Office tools: Word, Excel, PowerPoint, Outlook, Teams, etc.</li></ul>

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Principal/Staff Engineer - Process Development, CVD/Diffusion

Associate Director RA & QA

Principal R&D/Product Development Engineer (Remote)

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Principal/Staff Engineer - Process Development, CVD/Diffusion

Associate Director RA & QA

Principal R&D/Product Development Engineer (Remote)

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