Provide vision and leadership to strategic projects with significant site impact. Ensure new products are launched from the site in alignment with contract goals. Manage the performance of projects or significant subsystems associated with new products by influencing, coordinating, and driving activities, initiatives, and development deliverables across cross-functional teams. Direct all phases of new product development projects from inception through completion from an Operations perspective. Lead project review sessions focusing on cost, schedule, and technical performance. Establish milestones, monitor adherence to plans and schedules, identify issues, and implement solutions. Demonstrate strong leadership, clear communication, and the ability to build effective cross-functional working relationships. Ensure Value Improvement Projects (VIP) and new product initiatives are completed in alignment with contract expectations.
Key Responsibilities
· Project Planning & Definition: Define project goals, scope, resource and cost estimates, timeline, and risks. Facilitate cross-functional discussions to develop project proposals.
· People Leadership: Manage large, multi-project, multi-site cross-functional teams; provide performance input; foster strong alignment.
· Value Improvement (VIP): Oversee VIP initiatives; identify, communicate, and manage risks.
· Project / Program Management: Lead initiation, planning, execution, control, and close-out activities; ensure team ownership of plans, schedules, and budgets.
· Process Management: Ensure activities follow established processes; maintain documentation discipline; reinforce VIP and NPE best practices.
· Communications & Reviews: Drive cross-functional communication; serve as liaison between teams and leadership; lead phase reviews; maintain documentation including minutes, issue logs, and metrics.
· New Product Excellence (NPE): Implement NPE methods; manage NPE risks and deliverables.
Experience Requirements
· 5–7+ years of experience in manufacturing engineering or quality engineering within an FDA-regulated industry (medical devices, pharmaceuticals, biotechnology, diagnostics, or similar).
· Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485.
Read LessThe Process Development Engineer supports the development, validation, and implementation of new manufacturing processes. The role involves equipment and process
validation, documentation generation, process optimization, and cross-functional technical collaboration.
Responsibilities
Support IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.Design and develop in‑process and receiving inspection systems for new components and processes.Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.Manage process development projects from concept through implementation; collaborate with cross-functional teams.Apply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).Requirements
5–7+ years in manufacturing engineering or quality engineering within an FDA‑regulated environment (medical devices, pharma, diagnostics, biotech).Strong working knowledge of 21 CFR Part 820, GMP, and ISO 13485.Electrical and mechanical engineering background applied to automated manufacturing systems.Experience with automation/controls, tooling, fixtures, test method development, and equipment qualification.Proficiency in DOE, FMEA, CAPA, and root‑cause investigation.Experience supporting new product introductions and process scale‑up. Read LessAbout Company:
ShareTech Construction Group, LLC (SCG) is a local general contractor dedicated to provide state of the art construction services. SCG is managed by Professional Engineers and qualified resources to ensure quality, cost and time effective solution. SCG employees are trained in all aspects of construction standards, methodologies and technologies, potential risks in the workplace and are equipped with the required tools, and equipment to fulfill the Client’s needs and contract requirements.
About the Role:
The Estimator plays a critical role in the success of construction and project management by accurately assessing the costs associated with materials, labor, and time required to complete projects. This position involves analyzing project plans, specifications, and other documentation to prepare detailed and competitive cost estimates that support bidding and budgeting processes. The Estimator collaborates closely with project managers, engineers, and suppliers to ensure all factors influencing project costs are considered and accounted for. By providing precise and timely estimates, the Estimator helps the company make informed decisions, optimize resource allocation, and maintain profitability. Ultimately, this role ensures that projects are financially viable and aligned with client expectations and company goals.
Minimum Qualifications:
Bachelor’s degree in Civil or Mechanical Engineer.Proven experience 5+ years as an Estimator or in a similar role within the construction or engineering industry.Strong understanding of construction methods, materials, and cost estimation techniques.Proficiency in estimation software and Microsoft Office Suite.Excellent analytical, mathematical, and organizational skills.Preferred Qualifications:
Experience working in the Puerto Rico construction market or familiarity with local regulations and suppliers.Bilingual proficiency in English and Spanish.Strong negotiation and communication skills.Responsibilities:
Review and analyze blueprints, specifications, proposals, and other documentation to prepare accurate cost estimates.Consult with clients, vendors, and internal teams to gather necessary information and clarify project requirements.Calculate material, labor, and equipment costs, including subcontractor bids and overhead expenses.Prepare detailed bid proposals and present estimates to management and clients for approval.Maintain and update cost databases and estimation software to reflect current market prices and trends.Collaborate with project managers to monitor project budgets and provide cost control recommendations.Identify potential risks and opportunities in project scope that may impact costs and timelines.Skills:
The Estimator uses analytical skills daily to interpret complex project documents and translate them into accurate cost projections. Proficiency with estimation software and spreadsheets enables efficient calculation and adjustment of costs as project parameters evolve. Communication skills are essential for collaborating with clients, suppliers, and internal teams to gather information and present findings clearly. Organizational skills help manage multiple projects simultaneously, ensuring deadlines are met and data is meticulously maintained. Additionally, negotiation skills support securing competitive pricing from vendors and subcontractors, contributing to cost-effective project execution.
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